Actively Recruiting
Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)
Led by SOFIE · Updated on 2026-04-20
200
Participants Needed
10
Research Sites
107 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 pancreatic ductal adenocarcinoma. 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 Pancreatic Ductal Adenocarcinoma (PDAC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female adults 18 years or older
- Confirmed pancreatic ductal adenocarcinoma undergoing staging for treatment planning
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
- Signed informed consent before any study procedures
- Required to have a contrast-enhanced CT scan of chest, abdomen, and pelvis within 21 days before or planned within 21 days of [18F]FAPI-74 administration
- Women who are not postmenopausal or surgically sterile must agree to use effective contraception during the trial
You will not qualify if you...
- Clear evidence of metastases that rules out surgery at enrollment
- Known allergy to [18F]FAPI-74
- Received another investigational product within 30 days before [18F]FAPI-74 administration
- Received a radiopharmaceutical within 10 half-lives before [18F]FAPI-74 administration
- Previous cancer diagnosis except basal cell skin cancer or in situ cervical/uterine carcinoma unless disease-free for over 5 years
- Liver function with total bilirubin over 1.5 times upper limit or alkaline phosphatase, ALT, or AST over 5 times upper limit
- Kidney function with GFR less than 30 mL/min
- Pregnant or breastfeeding women (negative pregnancy test required for women of childbearing potential)
- Unable to undergo PET/CT scan
- Having inflammatory bowel disease like Crohn's disease or ulcerative colitis
- Having sarcoidosis
- Receiving treatment such as chemotherapy, radiation, or surgery for curative intent of PDAC
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, 44195
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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