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

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. 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

• [18F]FAPI-74 PET/CT · DRUG

  \[18F\]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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (15)

• Helios CR Inc./RadNet, Cerritos, California · RECRUITING
• City of Hope National Cancer Center, Duarte, California · RECRUITING
• Hoag Memorial Hospital, Irvine, California · RECRUITING
• UCLA, Los Angeles, California · RECRUITING
• Stanford University, Stanford, California · RECRUITING
• Moffit Cancer Center, Tampa, Florida · RECRUITING
• Indiana University Health University Hospital, Indianapolis, Indiana · RECRUITING
• Massachusetts General Hospital, Boston, Massachusetts · RECRUITING
• UMass/Shields, Worcester, Massachusetts · RECRUITING
• Mayo Clinic Rochester, Rochester, Minnesota · RECRUITING
• Icahn School of Medicine at Mount Sinai, New York, New York · NOT_YET_RECRUITING
• Memorial Sloan Kettering Cancer Center, New York, New York · RECRUITING
• Cleveland Clinic, Cleveland, Ohio · RECRUITING
• Kettering, Kettering, Ohio · RECRUITING
• University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania · RECRUITING