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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07217717
- Acronym / sponsor ID
- FAPI-PRO / 18FFAPI-2025P3-PDAC
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Keywords
- PDAC, FAP, FAPI, PET, Fibroblast Activation Protein, Fibroblast Activation Protein Inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- SOFIEIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pancreatic ductal adenocarcinoma receiving [18F]FAPI-74 | Experimental | Drug: [18F]FAPI-74 PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FAPI-74 PET/CT[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. | Drug | Patients with pancreatic ductal adenocarcinoma receiving [18F]FAPI-74 |
Primary outcome
Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference
Time frame: Time Frame: From enrollment to the end of treatment after 3 month follow up
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).
6 secondary outcomes
Incidence and severity of adverse events using CTCAE v5.
Time frame: 24-72 hours post-injection
Cohen's kappa for pairwise evaluation of inter- and intra-reader agreement
Time frame: 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
Time frame: 24-72 hours post-injection
Number of participants with treatment-related adverse events as assessed by blood pressure changes
Time frame: 24-72 hours post-injection
Number of participants with treatment-related adverse events as assessed by respiration rate
Time frame: 24-72 hours post-injection
Number of participants with treatment-related adverse events as assessed by pulse rate
Time frame: 24-72 hours post-injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sherly Mosessian, Ph.D study director
Sofie Co.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex Osipova (1-800-753-5368, Alex.osipova@sofie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference (time frame: Time Frame: From enrollment to the end of treatment after 3 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.