Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)
NCT ID: NCT07217717
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2025-12-11
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients with pancreatic ductal adenocarcinoma receiving [18F]FAPI-74
[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.
Interventions
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[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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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SOFIE
INDUSTRY
Responsible Party
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Principal Investigators
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Sherly Mosessian, Ph.D
Role: STUDY_DIRECTOR
Sofie Co.
Locations
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Helios CR Inc./RadNet
Cerritos, California, United States
Hoag Memorial Hospital
Irvine, California, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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18FFAPI-2025P3-PDAC
Identifier Type: -
Identifier Source: org_study_id
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