Back to resultsA Study to Evaluate Indocyanine Green Lymphangiography to Improve Lymphadenectomy in Gastric Cancer Patients
Primary Purpose
Gastric Cancer
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Indocyanine green
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients ≥ 18 and ≤ 75 years of age.
- Primary gastric adenocarcinoma of any histological subtype confirmed pathologically by endoscopic biopsy.
- Clinical stage tumor T1-4a (cT1-4a), N -/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition.
- No distant metastasis, no direct invasion of adjacent organs such as pancreas and spleen in preoperative exams.
- American Society of Anesthesiology score (ASA) class I, II, or III.
- Written informed consent.
Exclusion Criteria:
- Patients ≤ 18 and ≥ 75 years of age.
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy).
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection.
- History of allergy to iodine agents.
- History of other malignant disease within past five years.
- Emergency surgery due to complication caused by gastric cancer, such as bleeding obstruction or perforation.
- Patients intraoperatively/postoperatively confirmed as T4b.
- Patients intraoperatively confirmed as unable to complete D2 lymph node dissection or R0 dissection.
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention
Arm Description
Injection of Indocyamine Green.
Outcomes
Primary Outcome Measures
Positive ICG fluorescence lymph nodes
Total number of lymph nodes removed after surgery that are positive for ICG fluorescence
Disease positive lymph nodes
Number of ICG positive lymph nodes that are also positive for disease
Number of lymph nodes removed for each lymphatic station of gastrectomy
Total number of lymph nodes removed for each lymphatic station of gastrectomy with NIR+ICG vs gastrectomy without NIR+ICG
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04591028
Brief Title
A Study to Evaluate Indocyanine Green Lymphangiography to Improve Lymphadenectomy in Gastric Cancer Patients
Official Title
Indocyanine Green Lymphangiography as a Tool for Improving Lymphadenectomy in Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding.
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
August 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will be looking at the safety and added benefit of using the Indocyanine green dye (ICG) during surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Arm Description
Injection of Indocyamine Green.
Intervention Type
Drug
Intervention Name(s)
Indocyanine green
Intervention Description
A one time injection of IDC prior to the day of scheduled surgery.
Primary Outcome Measure Information:
Title
Positive ICG fluorescence lymph nodes
Description
Total number of lymph nodes removed after surgery that are positive for ICG fluorescence
Time Frame
Approximately 30-90 days after surgery
Title
Disease positive lymph nodes
Description
Number of ICG positive lymph nodes that are also positive for disease
Time Frame
Approximately 30-90 days after surgery
Title
Number of lymph nodes removed for each lymphatic station of gastrectomy
Description
Total number of lymph nodes removed for each lymphatic station of gastrectomy with NIR+ICG vs gastrectomy without NIR+ICG
Time Frame
Approximately 30-90 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients ≥ 18 and ≤ 75 years of age.
Primary gastric adenocarcinoma of any histological subtype confirmed pathologically by endoscopic biopsy.
Clinical stage tumor T1-4a (cT1-4a), N -/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition.
No distant metastasis, no direct invasion of adjacent organs such as pancreas and spleen in preoperative exams.
American Society of Anesthesiology score (ASA) class I, II, or III.
Written informed consent.
Exclusion Criteria:
Patients ≤ 18 and ≥ 75 years of age.
History of previous upper abdominal surgery (except laparoscopic cholecystectomy).
History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection.
History of allergy to iodine agents.
History of other malignant disease within past five years.
Emergency surgery due to complication caused by gastric cancer, such as bleeding obstruction or perforation.
Patients intraoperatively/postoperatively confirmed as T4b.
Patients intraoperatively confirmed as unable to complete D2 lymph node dissection or R0 dissection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique F Elli, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study to Evaluate Indocyanine Green Lymphangiography to Improve Lymphadenectomy in Gastric Cancer Patients
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