Back to resultsPrediction of Neoadjuvant Chemotherapy Efficacy in Locally Advanced Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastric Cancer
Eligibility Criteria
Inclusion criteria
- Age between 18-75 years.
- Histologically confirmed gastric adenocarcinoma through gastroscopy.
- Resectable gastric cancer.
- ECOG performance status 0-1.
- White blood count >4x109/L, Absolute neutrophil count (ANC) >2x109/L, Hemoglobin (Hb)>90g/L, Platelets >100x109/L.
- Ejection Fraction>50%.
- Serum bilirubin <1.5x ULN; ALT and AST <1.5x ULN.
- Serum creatinine ≤1.5x ULN, or GFR> 60ml/min.
- Agreement to participate in this study with informed consent form.
- Willingness and ability to comply with the protocol for the duration of the study.
- No children bearing petential in the next six months before enrollment.
Exclusion criteria
- With second primary malignant diseases in past five years, exceptions include basal cell and squamous cell carcinoma of the skin that have been cured.
- Known hypersensitivity reaction to chemotherapy drugs or with contraindications.
- With severe disease or other unsuitable conditions determined by investigators. Inadequate organ function.
- With uncontrollable diabetic or fasting blood glucose level ≥11 mmol/L on the test-day.
- With severe mental symptoms, unconscious or unable to complete the examination.
- Pregnancy or possibly pregnant woman, breastfeeding woman.
- Lack of compliance.
Sites / Locations
- Shanghai Ruijin HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET/CT for prediction of NAC efficacy
Arm Description
68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT will be scanned before, during or after NAC.
Outcomes
Primary Outcome Measures
Prediction for NAC efficacy
Predictive value of 68Ga-FAPI PET/CT and 18F-FDG PET/CT for LAGC in NAC response assessment.
Standardized uptake value(SUV)
SUV of 68Ga-FAPI and 18F-FDG uptake on PET/CT images for primary gastric cancer.
Target-to-background ratio(TBR)
68Ga-FAPI and 18F-FDG uptake ratio of primary gastric cancer to mediastinum blood pool on PET/CT images.
Secondary Outcome Measures
Diagnostic efficacy for metastatic lymph nodes
The sensitivity, specificity, NPV, PPV and accuracy of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with those of 18F-FDG PET/CT.
Disease free survival
Disease free survival
Overall survival
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05140746
Brief Title
Prediction of Neoadjuvant Chemotherapy Efficacy in Locally Advanced Gastric Cancer
Official Title
A Prospective Study on Predicting the Efficacy of Neoadjuvant Chemotherapy in Locally Advanced Gastric Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2020 (Actual)
Primary Completion Date
September 10, 2023 (Anticipated)
Study Completion Date
September 10, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study intends to explore the value of 68Ga-FAPI-04 and 18F-FDG PET/CT in the evaluation of treatment response to neoadjuvant chemotherapy(NAC) for patients with locally advanced gastric cancer(LAGC).
Detailed Description
Before the start of NAC, baseline 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT scans will be scheduled in all enrolled patients. Next, the patients with resectable LAGC will receive NAC treatment, surgery will follow 3~6 weeks after finishing NAC. Abdomen 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT will be scheduled after one cycle of NAC treatment or before surgery. Imaging response measurements will be compared with the histopathological tumor regression grade (TRG) of the resection specimen as gold standard.
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
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PET/CT for prediction of NAC efficacy
Arm Type
Experimental
Arm Description
68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT will be scanned before, during or after NAC.
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT
Intervention Description
Baseline 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT scans before NAC followed by abdomen 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT scans after one cycle of NAC treatment or before surgery.
Primary Outcome Measure Information:
Title
Prediction for NAC efficacy
Description
Predictive value of 68Ga-FAPI PET/CT and 18F-FDG PET/CT for LAGC in NAC response assessment.
Time Frame
Two weeks after surgery
Title
Standardized uptake value(SUV)
Description
SUV of 68Ga-FAPI and 18F-FDG uptake on PET/CT images for primary gastric cancer.
Time Frame
Two weeks after surgery
Title
Target-to-background ratio(TBR)
Description
68Ga-FAPI and 18F-FDG uptake ratio of primary gastric cancer to mediastinum blood pool on PET/CT images.
Time Frame
Two weeks after surgery
Secondary Outcome Measure Information:
Title
Diagnostic efficacy for metastatic lymph nodes
Description
The sensitivity, specificity, NPV, PPV and accuracy of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with those of 18F-FDG PET/CT.
Time Frame
Two weeks after surgery
Title
Disease free survival
Description
Disease free survival
Time Frame
5 years
Title
Overall survival
Description
Overall survival
Time Frame
5 years
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
Age between 18-75 years.
Histologically confirmed gastric adenocarcinoma through gastroscopy.
Resectable gastric cancer.
ECOG performance status 0-1.
White blood count >4x109/L, Absolute neutrophil count (ANC) >2x109/L, Hemoglobin (Hb)>90g/L, Platelets >100x109/L.
Ejection Fraction>50%.
Serum bilirubin <1.5x ULN; ALT and AST <1.5x ULN.
Serum creatinine ≤1.5x ULN, or GFR> 60ml/min.
Agreement to participate in this study with informed consent form.
Willingness and ability to comply with the protocol for the duration of the study.
No children bearing petential in the next six months before enrollment.
Exclusion criteria
With second primary malignant diseases in past five years, exceptions include basal cell and squamous cell carcinoma of the skin that have been cured.
Known hypersensitivity reaction to chemotherapy drugs or with contraindications.
With severe disease or other unsuitable conditions determined by investigators. Inadequate organ function.
With uncontrollable diabetic or fasting blood glucose level ≥11 mmol/L on the test-day.
With severe mental symptoms, unconscious or unable to complete the examination.
Pregnancy or possibly pregnant woman, breastfeeding woman.
Lack of compliance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Miao
Phone
0086-13671921521
Email
myada821@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenggang Zhu
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Runhua Feng
Phone
0086-13611920056
Email
frh10960@rjh.com.cn
First Name & Middle Initial & Last Name & Degree
Zhenggang Zhu
12. IPD Sharing Statement
Learn more about this trial
Prediction of Neoadjuvant Chemotherapy Efficacy in Locally Advanced Gastric Cancer
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