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Detecting Metastatic Pancreatic Cancer with 18F-FAPI PET

This study is looking at how well a special imaging test, called [18F]FAPI-74 PET/CT, can find pancreatic cancer that has spread to other parts of the body (metastatic disease). [18F]FAPI-74 is a diagnostic agent that helps light up certain cancer cells and cells around them during a PET scan. You may be able to join if you are an adult (18 or older) with confirmed pancreatic ductal adenocarcinoma (PDAC) and are undergoing evaluation for treatment. The researchers want to see how accurately this scan can detect metastatic disease compared to standard methods. The study plans to enroll 200 participants.

Study design
This is a multi-site, open-label (meaning you and your doctors will know what treatment you are receiving), non-randomized study. It will involve 200 participants.
What's involved
After screening, you will receive a single dose of [18F]FAPI-74 and undergo a PET/CT scan. Your standard of care (SOC) procedures and interventions will be recorded for about 3 months after the injection.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3 months +/- 14 days after the injection to capture standard of care procedures and interventions.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07217717

Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)

Recruiting
PHASE3Ages 18+InterventionalDiagnostic
SOFIE
~200 participants
Updated 2026-09-17 on ClinicalTrials.gov
What's tested:[18F]FAPI-74 PET/CT

At a glance

Recruiting sites
16 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference
Measured over Time Frame: From enrollment to the end of treatment after 3 month follow up

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Explore related trials

Pancreatic Ductal Adenocarcinoma

NCT07217717

Where you'd take part

This study runs at 16 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope National Cancer Center

    Duarte, Californiastudy coordinator listed

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Recruiting

  • Helios CR Inc./RadNet

    Cerritos, Californiastudy coordinator listed

    Recruiting

  • Hoag Memorial Hospital

    Irvine, Californiastudy coordinator listed

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Indiana University Health University Hospital

    Indianapolis, Indianastudy coordinator listed

    Recruiting

  • Kettering

    Kettering, Ohiostudy coordinator listed

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sherly Mosessian, Ph.D · STUDY_DIRECTOR · Sofie Co.

Who to contact

Alex Osipova
[email protected]
1-800-753-5368
Email the study team

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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.

What this trial measures

  • Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as referenceTime 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).