Gastric Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TEST68Ga-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.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Standardized uptake value(SUV) | Two weeks after surgery | SUV of 68Ga-FAPI and 18F-FDG uptake on PET/CT images for primary gastric cancer. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Disease free survival | 5 years | Disease free survival |
| Overall survival | 5 years | Overall survival |
Countries
China
Contacts
Primary ContactYing Miao
Outcome results
None listed