Prediction of Neoadjuvant Chemotherapy Efficacy in Locally Advanced Gastric Cancer

January 8, 2024 updated by: Ruijin Hospital

A Prospective Study on Predicting the Efficacy of Neoadjuvant Chemotherapy in Locally Advanced Gastric Cancer.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Shanghai Ruijin Hospital
        • Contact:
        • Principal Investigator:
          • Zhenggang Zhu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  1. Age between 18-75 years.
  2. Histologically confirmed gastric adenocarcinoma through gastroscopy.
  3. Resectable gastric cancer.
  4. ECOG performance status 0-1.
  5. White blood count >4x109/L, Absolute neutrophil count (ANC) >2x109/L, Hemoglobin (Hb)>90g/L, Platelets >100x109/L.
  6. Ejection Fraction>50%.
  7. Serum bilirubin <1.5x ULN; ALT and AST <1.5x ULN.
  8. Serum creatinine ≤1.5x ULN, or GFR> 60ml/min.
  9. Agreement to participate in this study with informed consent form.
  10. Willingness and ability to comply with the protocol for the duration of the study.
  11. No children bearing petential in the next six months before enrollment.

Exclusion criteria

  1. With second primary malignant diseases in past five years, exceptions include basal cell and squamous cell carcinoma of the skin that have been cured.
  2. Known hypersensitivity reaction to chemotherapy drugs or with contraindications.
  3. With severe disease or other unsuitable conditions determined by investigators. Inadequate organ function.
  4. With uncontrollable diabetic or fasting blood glucose level ≥11 mmol/L on the test-day.
  5. With severe mental symptoms, unconscious or unable to complete the examination.
  6. Pregnancy or possibly pregnant woman, breastfeeding woman.
  7. Lack of compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET/CT for prediction of NAC efficacy
68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT will be scanned before, during or after NAC.
Diagnostic test: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Overall survival
5 years
Disease free survival
Time Frame: 5 years
Disease free survival
5 years
Diagnostic efficacy for metastatic lymph nodes
Time Frame: 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.
Two weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Principal Investigator: Zhenggang Zhu, Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2020

Primary Completion (Estimated)

September 10, 2024

Study Completion (Estimated)

September 10, 2027

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria

November 21, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PET-NAC-GC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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