Prediction of Neoadjuvant Chemotherapy Efficacy in Locally Advanced Gastric Cancer

Not Applicable

Recruiting

• Conditions: Gastric Cancer
• Interventions: Diagnostic Test: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT

• Registration Number: NCT05140746
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study Start: 2020-09-10
• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-21
• Study First Posted: 2021-12-01
• Status Verified: 2023-12
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09
• Primary Completion: 2024-09-10
• Study Completion: 2027-09-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET/CT for prediction of NAC efficacy	68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT	68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT will be scanned before, during or after NAC.

Primary Outcome Measures

Name	Time	Method
Standardized uptake value(SUV)	Two weeks after surgery	SUV of 68Ga-FAPI and 18F-FDG uptake on PET/CT images for primary gastric cancer.
Prediction for NAC efficacy	Two weeks after surgery	Predictive value of 68Ga-FAPI PET/CT and 18F-FDG PET/CT for LAGC in NAC response assessment.
Target-to-background ratio(TBR)	Two weeks after surgery	68Ga-FAPI and 18F-FDG uptake ratio of primary gastric cancer to mediastinum blood pool on PET/CT images.

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	Overall survival
Disease free survival	5 years	Disease free survival
Diagnostic efficacy for metastatic lymph nodes	Two weeks after surgery	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.

Trial Locations

Locations (1)

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China