Actively Recruiting
Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.
Led by SOFIE · Updated on 2026-04-20
200
Participants Needed
10
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of \[¹⁸F\]FAPI-74 PET/CT in the detection of metastatic disease in individuals with pathologically confirmed gastric, gastroesophageal junction or esophageal cancer. Following screening, using a standardized administration protocol and dose, participants will undergo \[¹⁸F\]FAPI-74 PET/CT screening. SOC procedures and interventions will be captured during 3 months +/-14 days post injection. The primary objective is to evaluate the sensitivity and specificity of such \[¹⁸F\]FAPI-74 PET/CT using a composite SOT panel. The maximum expected duration of the trial is approximately 24 months from first patient screening to last patient SOC follow up. The participants will be followed-up for safety for 24 to 72 hours after the dose of \[¹⁸F\]FAPI-74 PET/CT.
CONDITIONS
Official Title
Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Confirmed diagnosis of gastric, esophageal, or gastroesophageal junction cancer undergoing staging for treatment planning
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Signed, written informed consent before any study procedures
- Contrast-enhanced CT scan of chest, abdomen, and pelvis within 21 days before or planned within 21 days after [18F]FAPI-74 administration
- For women not postmenopausal or surgically sterile: agreement to use effective contraception during the trial intervention period
You will not qualify if you...
- Clear evidence of metastases at enrollment that prevents surgery as a treatment option
- Known allergy to [18F]FAPI-74
- Use of other investigational diagnostic or therapeutic products within 30 days before [18F]FAPI-74 administration
- Prior radiopharmaceutical treatment within 10 half-lives before [18F]FAPI-74 administration
- Previous cancer except certain skin or cervical cancers treated curatively and disease-free for over 5 years
- Liver function tests above specified limits (total bilirubin >1.5 times upper limit normal, or alkaline phosphatase, ALT, AST >5 times upper limit normal)
- Kidney function with glomerular filtration rate below 30 mL/min
- Pregnant or breastfeeding women
- Unable to undergo PET/CT scan
- Inflammatory bowel disease including Crohn's disease or ulcerative colitis
- Sarcoidosis
- Prior treatment for curative intent of gastroesophageal cancers including chemotherapy, radiation, immunotherapy, or surgery
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Helios CR Inc./RadNet
Cerritos, California, United States, 90703
Actively Recruiting
2
Hoag Memorial Hospital
Irvine, California, United States, 92618
Actively Recruiting
3
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
4
Moffit Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
Indiana University Health University Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
6
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
UMass/Shields
Worcester, Massachusetts, United States, 01655
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
9
Cleveland Clinic
Cleveland, Ohio, United States, 44194
Actively Recruiting
10
Kettering
Kettering, Ohio, United States, 45429
Actively Recruiting
Research Team
A
Alex Osipova
CONTACT
B
Bridget Adams
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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