Status:
RECRUITING
Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)
Lead Sponsor:
SOFIE
Conditions:
Pancreatic Ductal Adenocarcinoma (PDAC)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 co...
Eligibility Criteria
Inclusion
- Male and female adults ≥ 18 years.
- Participants with confirmed PDAC, undergoing staging evaluation for treatment planning.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2:
- Provided signed, written informed consent obtained prior to any study-related procedures.
- Participants are required to have a ceCT scan of chest, abdomen and pelvis as per standard clinical practice and practice guidelines either 21 days or less prior to entry or planned within 21 days of \[¹⁸F\]FAPI-74 administration.
- For women who are not postmenopausal (two years of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use medically accepted, highly effective methods of contraception (e.g., hormonal implants, combined oral contraceptives, vasectomized partner , during the trial intervention period.
Exclusion
- Unequivocal evidence of metastases at the time of enrollment that would preclude surgery as a treatment option.
- Known hypersensitivity to \[¹⁸F\]FAPI-74.
- Administration of another investigational therapeutic or diagnostic product within 30 days prior to \[¹⁸F\]FAPI-74 administration.
- Prior administration of a radiopharmaceutical within 10 half-lives of that product from the time of \[¹⁸F\]FAPI-74 administration.
- Previous cancer diagnosis (except basal cell carcinoma of the skin or in situ carcinoma of the cervix/uterus). Participants treated with curative intent and disease-free for more than 5 years are permitted.
- Hepatic function: T. bili \>1.5X ULN or alk phos, ALT, or AST \>5X ULN
- Renal function: GFR \< 30 mL/min
- Pregnant or breast feeding (a negative pregnancy test is required in women of childbearing potential)
- Inability to undergo the PET/CT scanning procedure.
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Sarcoidosis
- Treatment, including chemotherapy, radiation or surgery for curative intent of PDAC.
Key Trial Info
Start Date :
December 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07217717
Start Date
December 11 2025
End Date
December 31 2027
Last Update
December 15 2025
Active Locations (3)
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1
Helios CR Inc./RadNet
Cerritos, California, United States, 90703
2
Hoag Memorial Hospital
Irvine, California, United States, 92618
3
Indiana University Health University Hospital
Indianapolis, Indiana, United States, 46202