Pancreatic Ductal Adenocarcinoma (PDAC)Phase 3FAPI-PRONCT07217717
Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)
A Phase 3 study testing [18F]FAPI-74 PET/CT in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by SOFIE at 19 sites in United States.
Trial 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 confirmed pancreatic ductal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- [18F]FAPI-74 PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 19 sitesUnited States
- Study dates
- 11 Dec 2025to 31 Dec 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
United States19 sites, 19 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Isabelle Lin, 617-643-6837, ilin4@mgh.harvard.edu
Shadi Esfahani, MD
- Recruiting
Helios CR Inc./RadNet
Cerritos, California, 90703
Sabrina Mora, 562-693-4477, Sabrina.mora@heliosclinical.com
Alexis Velasco, alexis.velasco@heliosclinical.com
- Not yet recruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611
Forest Hynes, 3126949930, forest.hynes@nm.org
Ryan Avery, MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Molly Haberkorn, 216-445-6434, HABERKS@ccf.org
Nicholas Austin, DO
- Recruiting
Impression Imaging
Coral Springs, Florida, 33065
Isaiah Brazle, 9543480103, ibrazle@impressionimaging.com
Michael Fagien, MD
- Recruiting
City of Hope National Cancer Center
Duarte, California, 91010
Miranda Qian, (626) 218-3533, lqian@coh.org
Yufei Liu, M.D, Ph.D
- Recruiting
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
Eric Grubbs, (317) 274-2584, eegrubbs@iu.edu
Cindy Yuan, MD PhD
- Recruiting
Hoag Memorial Hospital
Irvine, California, 92618
Beth Thomsen, 949-557-0285, Beth.thomsen@hoag.org
Gary Ulaner, MD
- Not yet recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Chyann Moore, 507-266-6759, Moore.chyann@mayo.edu
Hani Babiker, MD
- Recruiting
Kettering
Kettering, Ohio, 45429
Kathren Garber, 937-395-8390, kathren.garber@ketteringhealth.org
Arif Sheikh, MD
- Recruiting
UCLA
Los Angeles, California, 90095
Steven Stokes, 310 206-7436, SStokes@mednet.ucla.edu
Mark Girgis, MD
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Kyersten Hoene, 9209796340, khoene@mcw.edu
Michael Holt, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Ilda Bander, 212-241-0763, Ilda.bander@mountsinai.org
Sampanna Rayamajhi, MD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Jordayna Francois, (646)888-6819, francoij@mskcc.org
Aria Razmari, MD
- Recruiting
University of Pennsylvania, Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
Erin Schubert, 215-573-6569, Erin.schubert@pennmedicine.upenn.edu
Mark Sellmyer, MD, PhD
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Kera Delaney, 507-293-2227, delaney.kera@mayo.edu
Ajit H Goenka, MD
- Recruiting
Stanford University
Stanford, California, 94305
Kavin Tamizhmani, (650)-497-6046, ktamizhm@stanford.edu
Matteo Novello, MD
- Recruiting
Moffit Cancer Center
Tampa, Florida, 33612
Jacqueline Guillermo Adams, 813-745-2468, Jacqueline.GuillermoAdams@moffitt.org
Ghassan El-Haddad, MD
- Recruiting
UMass/Shields
Worcester, Massachusetts, 01655
Sara Schiller, 774-548-1090, sara.schiller1@umassmed.edu
Elisa Franquet-Elia, MD
About this study
Official title: A Phase 3, Multicenter, Prospective Open-Label Study of the Diagnostic Performance of [¹⁸F]FAPI-74 PET/CT for the Detection of Metastatic Disease in Adults With Pancreatic Ductal Adenocarcinoma
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
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- [18F]FAPI-74 PET/CT
- Keywords
- PDAC, FAP, FAPI, PET, Fibroblast Activation Protein, Fibroblast Activation Protein Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FAPI-74 PET/CTDrug
[18F]FAPI-74 is a radioactive diagnostic agent indicated for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) in patients with pancreatic ductal adenocarcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pancreatic ductal adenocarcinoma receiving [18F]FAPI-74 | Experimental | Not described Receives: Drug: [18F]FAPI-74 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference
To evaluate the diagnostic performance of [¹⁸F]FAPI-74 PET/CT scan in determining the presence or absence of metastatic disease (M1) in patients with pancreatic ductal adenocarcinoma compared with a composite standard of truth (SOT).
Measured: Time Frame: From enrollment to the end of treatment after 3 month follow up
Secondary outcomes (6)
Incidence and severity of adverse events using CTCAE v5.
To assess the safety profile of [¹⁸F]FAPI-74 PET/CT.
Measured: 24-72 hours post-injection
Cohen's kappa for pairwise evaluation of inter- and intra-reader agreement
To assess inter-and intra-reader variability in image interpretation of the presence of metastatic disease
Measured: From enrollment to the end of treatment after 3 month follow up
Number of participants with treatment-related adverse events as assessed by body temperature changes
To assess the safety profile of [¹⁸F]FAPI-74 PET/CT.
Measured: 24-72 hours post-injection
Number of participants with treatment-related adverse events as assessed by blood pressure changes
To assess the safety profile of [¹⁸F]FAPI-74
Measured: 24-72 hours post-injection
Number of participants with treatment-related adverse events as assessed by respiration rate
To assess the safety profile of [¹⁸F]FAPI-74
Measured: 24-72 hours post-injection
Number of participants with treatment-related adverse events as assessed by pulse rate
To assess the safety profile of [¹⁸F]FAPI-74
Measured: 24-72 hours post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start11 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SOFIE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sherly Mosessian, Ph.D, Study director, Sofie Co.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217717
- Sponsor's protocol ID
- 18FFAPI-2025P3-PDAC
- Acronym
- FAPI-PRO
- Status last verified
- Jan 2026
- First submitted
- 14 Oct 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No