Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [18F]FAPI-74 PET/CT.
- Who it may be relevant to
- Registry conditions: Pancreatic Ductal Adenocarcinoma (PDAC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug [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.
Primary outcome measures
- 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]
Secondary outcome measures (6)
- 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]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 15 centers
- Helios CR Inc./RadNet — Cerritos
- City of Hope National Cancer Center — Duarte
- Hoag Memorial Hospital — Irvine
- UCLA — Los Angeles
- Stanford University — Stanford
- Moffit Cancer Center — Tampa
- Indiana University Health University Hospital — Indianapolis
- Massachusetts General Hospital — Boston
- … and 7 more centers
Identifiers
NCT: NCT07217717 · 18FFAPI-2025P3-PDAC