Back to resultsSLN Detection With Tc-MSA-ICG in Lung Cancer Patients
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Early Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
99mTc-MSA-ICG
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring Lung Cancer, Sentinel lymph node, Radioactive fluorescent dual contrast agent
Eligibility Criteria
Inclusion Criteria:
Preoperative examinations (chest CT, PET/CT, bone scan, brain MRI) diagnosed the clinical stage as T1a or T1b with the size the cancer less than 2 cm and adenocarcinoma or square cell carcinoma through preoperative biopsy, with no lymph node or other diseases and lung disease. A person who meets the conditions described below and does not fall under the exclusion criteria is selected as an adult.
- Eastern cooperative oncology group (ECOG) performance scale: 0~2
- White blood cell count ≥ 3,000/㎣ and ≤ 12,000/㎣
- Neutrophil count ≥ 1,500/㎣
- Platelet count ≥ 100,000/㎣
- AST, ALT ≤ 2.5 times the upper limit
- Total bilirubin ≤ 2.5 times the upper limit
- Serum creatinine ≤ 1.5 time the upper limit
Exclusion Criteria:
- Those who do not agree or refuse to participate in the research
- A person who is not suitable for general anesthesia
- A person with a clinically significant acute or unstable condition
A person with the following serious heart disease
- congestive heart failure with symptoms
- New York Heart Association III/IV Class Heart Disease
- Unstable angina
- Symptom or unregulated heart arrhythmia
- Myocardial infarction within the past three months
- QT interval (QTcF) using Fridricia calibration
- Family history of long QT syndrome
- Those who cannot be scanned (e.g., patients with claustrophobia, ect.)
- A person who received a therapeutic radiation dose within four weeks prior to participation in the study ([18F]FDG has a half-life of 109 minutes, so after 18.2 hours, 99mTc-MDP has a half-life of 6 hours, that is after 2.5 days)
- A person who is being administered drugs such as a drug metabolic enzyme inducer or inhibitor within four weeks before participating in the study
- A person who has overreacted or had side effects on clinical research medications (ICG or 99mTc).
- Patients with closed diseases
- Patients with iodine intolerance
- In the case of pregnant women/feeding mothers or pregnant women, those who do not agree to the use of appropriate contraception methods during the research period;
- A person who participated in another clinical study within 12 weeks before participating in the study and administered clinical research medications or received medical device procedures for clinical research.
- Those who are unfit to participate in this clinical study in the judgment of the research manager
Sites / Locations
- Korea University Guro HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
99mTc-MSA-ICG injection
Arm Description
99mTc-MSA-ICG injection 1mCi of 99mTc 1mg of MSA 0.1mg of ICG Total 1cc injection volume at 2 hours before the surgery
Outcomes
Primary Outcome Measures
Clinical chemistry examination-1 (CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic)
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery. (mg/dL)
Clinical chemistry examination-2
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients on postoperativeday(POD) 0 (mg/dL)
Clinical chemistry examination-3
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients on POD 1 (mg/dL)
Clinical chemistry examination-4
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients on POD 5 (mg/dL)
Clinical chemistry examination-5
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery. (ng/mL)
Clinical chemistry examination-6
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 0 (ng/mL)
Clinical chemistry examination-7
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 1 (ng/mL)
Clinical chemistry examination-8
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 5 (ng/mL)
Clinical chemistry examination-9
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (IU/L)
Clinical chemistry examination-10
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients on POD 0 (IU/L)
Clinical chemistry examination-11
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients on POD 1 (IU/L)
Clinical chemistry examination-12
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients on POD 5 (IU/L)
Clinical chemistry examination-13
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (mmol/L)
Clinical chemistry examination-14
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients on POD 0 (mmol/L)
Clinical chemistry examination-15
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients on POD 1 (mmol/L)
Clinical chemistry examination-16
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients on POD 5 (mmol/L)
Hematology examination-1
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery(mEq/L)
Hematology examination-2
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 0 (mEq/L)
Hematology examination-3
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 1 (mEq/L)
Hematology examination-4
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 5 (mEq/L)
Hematology examination-5
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (g/dL)
Hematology examination-6
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 0 (g/dL)
Hematology examination-7
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 1 (g/dL)
Hematology examination-8
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 5 (g/dL)
Hematology examination-9
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (%)
Hematology examination-10
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD0 (%)
Hematology examination-11
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD1 (%)
Hematology examination-12
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD5 (%)
Hematology examination-13
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (10³/μl)
Hematology examination-14
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients on POD0 (10³/μl)
Hematology examination-15
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients on POD1 (10³/μl)
Hematology examination-16
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients on POD5 (10³/μl)
Hematology examination-17
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery(fL)
Hematology examination-18
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 0 (fL)
Hematology examination-19
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 1(fL)
Hematology examination-20
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 5 (fL)
Hematology examination- 21
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (pg)
Hematology examination- 22
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients and POD 0 (pg)
Hematology examination- 23
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients on POD 1 (pg)
Hematology examination- 24
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients on POD 5 (pg)
Hematology examination- 25
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (sec)
Hematology examination- 26
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 0 (sec)
Hematology examination- 27
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 1 (sec)
Hematology examination- 28
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 5 (sec)
Check for changes of urinalysis-1
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) within two weeks before surgery (number)
Check for changes of urinalysis-2
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 0 (number)
Check for changes of urinalysis-3
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 1(number)
Check for changes of urinalysis-4
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 5 (number)
Check for changes of urinalysis-5
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (0 or +1)
Check for changes of urinalysis-6
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients on POD 0 (0 or +1)
Check for changes of urinalysis-7
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients on POD 1 (0 or +1)
Check for changes of urinalysis-8
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients on POD 5 (0 or +1)
Check for changes of urinalysis-9
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery(4 - 0 / HPF
Check for changes of urinalysis-10
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients on POD 0 (4 - 0 / HPF)
Check for changes of urinalysis-11
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients on POD 1 (4 - 0 / HPF)
Check for changes of urinalysis-12
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients on POD 5 (4 - 0 / HPF)
Observation of the irritable adverse reaction
Observation of the irritable adverse reaction (Urticaria, angioedema, allergic rhinitis, anaphylaxis, exanthermatous eruption, fixed drug eruption, acneiform eruption, purpura eruption, urticarial eruption, bullous eruption, lichenoid eruption, Stevens-Johnson syndrom, acute generalized exanthematous pustulosis, toxic epidermal necrolysis) to check the drug-related safety in 10 lung cancer patients
Effective dose measurement
Secondary Outcome Measures
Confirm the sentinel lymph node identification rate
Calculation the percentage of cancer cells found in pathological test among sentinel lymph nodes where fluorescent or nuclear signal are detected.
Confirm the false negative rate
Calculation the proportion of cancer cells found in pathological tests among non-sentinel lymph nodes where no fluorescent or nuclear signals were detected.
Full Information
NCT ID
NCT05039905
First Posted
February 15, 2021
Last Updated
September 9, 2021
Sponsor
Korea University Guro Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05039905
Brief Title
SLN Detection With Tc-MSA-ICG in Lung Cancer Patients
Official Title
Development of the Surgical Technique Using Radioactive Fluorescent Dual Contrast Agent for Intraoperative Sentinel Lymph Node Detection in Lung Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Guro Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is necessary to develop a technique of sentinel lymph node detection using radioactive fluorescent dual contrast agent consisting targetable albumin for specific marker to accurately determine whether or not the sentinel lymph nodes have metastasized or non-metastasized. Therefore, investigators would like to conduct a clinical trial to evaluate the effectiveness of radioactive fluorescent dual contrast agent to detect sentinel lymph nodes for patient-specific minimally invasive surgery.
Detailed Description
It is necessary to develop a technique of sentinel lymph node detection using radioactive fluorescent dual contrast agent consisting targetable albumin for specific marker to accurately determine whether or not the sentinel lymph nodes have metastasized or non-metastasized. Therefore, investigators would like to conduct a clinical trial to evaluate the effectiveness of radioactive fluorescent dual contrast agent (99mTc-MSA-ICG) to detect sentinel lymph nodes for patient-specific minimally invasive surgery.
To analyze the effectiveness of radioactive fluorescent dual contrast agent (99mTc-MSA-ICG) for detecting sentinel lymph node, total 10 lung cancer patients will participate in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung Cancer, Sentinel lymph node, Radioactive fluorescent dual contrast agent
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Lung cancer patient
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
99mTc-MSA-ICG injection
Arm Type
Experimental
Arm Description
99mTc-MSA-ICG injection
1mCi of 99mTc
1mg of MSA 0.1mg of ICG Total 1cc injection volume at 2 hours before the surgery
Intervention Type
Drug
Intervention Name(s)
99mTc-MSA-ICG
Intervention Description
Intratumoral injection of 99mTechnetium-manosylated albumin-indocyanine green to lung cancer patients
Primary Outcome Measure Information:
Title
Clinical chemistry examination-1 (CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic)
Description
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery. (mg/dL)
Time Frame
Within two weeks before surgery
Title
Clinical chemistry examination-2
Description
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients on postoperativeday(POD) 0 (mg/dL)
Time Frame
postoperative day 0
Title
Clinical chemistry examination-3
Description
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients on POD 1 (mg/dL)
Time Frame
postoperative day 1
Title
Clinical chemistry examination-4
Description
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients on POD 5 (mg/dL)
Time Frame
postoperative day 5
Title
Clinical chemistry examination-5
Description
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery. (ng/mL)
Time Frame
within two weeks before surgery
Title
Clinical chemistry examination-6
Description
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 0 (ng/mL)
Time Frame
postoperative day 0
Title
Clinical chemistry examination-7
Description
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 1 (ng/mL)
Time Frame
postoperative day 1
Title
Clinical chemistry examination-8
Description
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 5 (ng/mL)
Time Frame
postoperative day 5
Title
Clinical chemistry examination-9
Description
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (IU/L)
Time Frame
within two weeks before surgery
Title
Clinical chemistry examination-10
Description
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients on POD 0 (IU/L)
Time Frame
postoperative day 0
Title
Clinical chemistry examination-11
Description
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients on POD 1 (IU/L)
Time Frame
postoperative day 1
Title
Clinical chemistry examination-12
Description
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients on POD 5 (IU/L)
Time Frame
postoperative day 5
Title
Clinical chemistry examination-13
Description
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (mmol/L)
Time Frame
within two weeks before surgery
Title
Clinical chemistry examination-14
Description
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients on POD 0 (mmol/L)
Time Frame
postoperative day 0
Title
Clinical chemistry examination-15
Description
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients on POD 1 (mmol/L)
Time Frame
postoperative day 1
Title
Clinical chemistry examination-16
Description
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients on POD 5 (mmol/L)
Time Frame
postoperative day 5
Title
Hematology examination-1
Description
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery(mEq/L)
Time Frame
within two weeks before surgery
Title
Hematology examination-2
Description
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 0 (mEq/L)
Time Frame
postoperative day 0
Title
Hematology examination-3
Description
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 1 (mEq/L)
Time Frame
postoperative day 1
Title
Hematology examination-4
Description
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 5 (mEq/L)
Time Frame
postoperative day 5
Title
Hematology examination-5
Description
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (g/dL)
Time Frame
within two weeks before surgery
Title
Hematology examination-6
Description
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 0 (g/dL)
Time Frame
postoperative day 0
Title
Hematology examination-7
Description
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 1 (g/dL)
Time Frame
postoperative day 1
Title
Hematology examination-8
Description
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 5 (g/dL)
Time Frame
postoperative day 5
Title
Hematology examination-9
Description
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (%)
Time Frame
within two weeks before surgery
Title
Hematology examination-10
Description
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD0 (%)
Time Frame
postoperative day 0
Title
Hematology examination-11
Description
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD1 (%)
Time Frame
postoperative day 1
Title
Hematology examination-12
Description
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD5 (%)
Time Frame
postoperative day 5
Title
Hematology examination-13
Description
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (10³/μl)
Time Frame
within two weeks before surgery
Title
Hematology examination-14
Description
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients on POD0 (10³/μl)
Time Frame
postoperative day 0
Title
Hematology examination-15
Description
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients on POD1 (10³/μl)
Time Frame
postoperative day 1
Title
Hematology examination-16
Description
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients on POD5 (10³/μl)
Time Frame
postoperative day 5
Title
Hematology examination-17
Description
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery(fL)
Time Frame
within two weeks before surgery
Title
Hematology examination-18
Description
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 0 (fL)
Time Frame
postoperative day 0
Title
Hematology examination-19
Description
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 1(fL)
Time Frame
postoperative day 1
Title
Hematology examination-20
Description
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 5 (fL)
Time Frame
postoperative day 5
Title
Hematology examination- 21
Description
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (pg)
Time Frame
within two weeks before surgery
Title
Hematology examination- 22
Description
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients and POD 0 (pg)
Time Frame
postoperative day 0
Title
Hematology examination- 23
Description
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients on POD 1 (pg)
Time Frame
postoperative day 1
Title
Hematology examination- 24
Description
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients on POD 5 (pg)
Time Frame
postoperative day 5
Title
Hematology examination- 25
Description
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (sec)
Time Frame
within two weeks before surgery
Title
Hematology examination- 26
Description
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 0 (sec)
Time Frame
postoperative day 0
Title
Hematology examination- 27
Description
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 1 (sec)
Time Frame
postoperative day 1
Title
Hematology examination- 28
Description
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 5 (sec)
Time Frame
postoperative day 5
Title
Check for changes of urinalysis-1
Description
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) within two weeks before surgery (number)
Time Frame
within two weeks before surgery
Title
Check for changes of urinalysis-2
Description
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 0 (number)
Time Frame
postoperative day 0
Title
Check for changes of urinalysis-3
Description
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 1(number)
Time Frame
postoperative day 1
Title
Check for changes of urinalysis-4
Description
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 5 (number)
Time Frame
postoperative day 5
Title
Check for changes of urinalysis-5
Description
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (0 or +1)
Time Frame
within two weeks before surgery
Title
Check for changes of urinalysis-6
Description
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients on POD 0 (0 or +1)
Time Frame
postoperative day 0
Title
Check for changes of urinalysis-7
Description
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients on POD 1 (0 or +1)
Time Frame
postoperative day 1
Title
Check for changes of urinalysis-8
Description
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients on POD 5 (0 or +1)
Time Frame
postoperative day 5
Title
Check for changes of urinalysis-9
Description
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery(4 - 0 / HPF
Time Frame
within two weeks before surgery
Title
Check for changes of urinalysis-10
Description
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients on POD 0 (4 - 0 / HPF)
Time Frame
postoperative day 0
Title
Check for changes of urinalysis-11
Description
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients on POD 1 (4 - 0 / HPF)
Time Frame
postoperative day 1
Title
Check for changes of urinalysis-12
Description
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients on POD 5 (4 - 0 / HPF)
Time Frame
postoperative day 5
Title
Observation of the irritable adverse reaction
Description
Observation of the irritable adverse reaction (Urticaria, angioedema, allergic rhinitis, anaphylaxis, exanthermatous eruption, fixed drug eruption, acneiform eruption, purpura eruption, urticarial eruption, bullous eruption, lichenoid eruption, Stevens-Johnson syndrom, acute generalized exanthematous pustulosis, toxic epidermal necrolysis) to check the drug-related safety in 10 lung cancer patients
Time Frame
Up to 2 hours after drug injection
Title
Effective dose measurement
Time Frame
Up to five days after surgery
Secondary Outcome Measure Information:
Title
Confirm the sentinel lymph node identification rate
Description
Calculation the percentage of cancer cells found in pathological test among sentinel lymph nodes where fluorescent or nuclear signal are detected.
Time Frame
Through study completion, an average of 1 year
Title
Confirm the false negative rate
Description
Calculation the proportion of cancer cells found in pathological tests among non-sentinel lymph nodes where no fluorescent or nuclear signals were detected.
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preoperative examinations (chest CT, PET/CT, bone scan, brain MRI) diagnosed the clinical stage as T1a or T1b with the size the cancer less than 2 cm and adenocarcinoma or square cell carcinoma through preoperative biopsy, with no lymph node or other diseases and lung disease. A person who meets the conditions described below and does not fall under the exclusion criteria is selected as an adult.
Eastern cooperative oncology group (ECOG) performance scale: 0~2
White blood cell count ≥ 3,000/㎣ and ≤ 12,000/㎣
Neutrophil count ≥ 1,500/㎣
Platelet count ≥ 100,000/㎣
AST, ALT ≤ 2.5 times the upper limit
Total bilirubin ≤ 2.5 times the upper limit
Serum creatinine ≤ 1.5 time the upper limit
Exclusion Criteria:
Those who do not agree or refuse to participate in the research
A person who is not suitable for general anesthesia
A person with a clinically significant acute or unstable condition
A person with the following serious heart disease
congestive heart failure with symptoms
New York Heart Association III/IV Class Heart Disease
Unstable angina
Symptom or unregulated heart arrhythmia
Myocardial infarction within the past three months
QT interval (QTcF) using Fridricia calibration
Family history of long QT syndrome
Those who cannot be scanned (e.g., patients with claustrophobia, ect.)
A person who received a therapeutic radiation dose within four weeks prior to participation in the study ([18F]FDG has a half-life of 109 minutes, so after 18.2 hours, 99mTc-MDP has a half-life of 6 hours, that is after 2.5 days)
A person who is being administered drugs such as a drug metabolic enzyme inducer or inhibitor within four weeks before participating in the study
A person who has overreacted or had side effects on clinical research medications (ICG or 99mTc).
Patients with closed diseases
Patients with iodine intolerance
In the case of pregnant women/feeding mothers or pregnant women, those who do not agree to the use of appropriate contraception methods during the research period;
A person who participated in another clinical study within 12 weeks before participating in the study and administered clinical research medications or received medical device procedures for clinical research.
Those who are unfit to participate in this clinical study in the judgment of the research manager
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Koo Kim, MD, PhD
Phone
82-2-2626-3106
Email
kimhyunkoo@korea.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jiyun Rho, BA
Phone
82-2-2626-1978
Email
jiyun.r1219@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Koo Kim, MD, PhD
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiyun Rho, BA
Phone
82-2-2626-1978
Email
jiyun.r1219@gmail.com
First Name & Middle Initial & Last Name & Degree
Seunghoe Song, MBE
Phone
82-2-2626-1635
Email
ssessong@korea.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SLN Detection With Tc-MSA-ICG in Lung Cancer Patients
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