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

RecruitingPhase 3

Sponsor: SOFIE

Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions: [18F]FAPI-74 PET/CT

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (15)

Cerritos, California, United States
Duarte, California, United States
Irvine, California, United States
Los Angeles, California, United States
Stanford, California, United States
Tampa, Florida, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Rochester, Minnesota, United States
New York, New York, United States
New York, New York, United States
Cleveland, Ohio, United States
Kettering, Ohio, United States
Philadelphia, Pennsylvania, United States