Clinical Trial 24073

• Overview

  Study Title:

  A Phase 3, Multicenter, Prospective Open-Label Study to Evaluate the Diagnostic Performance of [18F] FAPI-74 PET/CT for the Detection of Metastatic Disease in Adults with Pancreatic Ductal Adenocarcinoma (FAPI-PRO)

  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.

  Objective:

  Primary Objective: - 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) Safety Objective: - To assess the safety profile of [18F]FAPI-74 PET/CT Secondary Objective: - To assess inter-and intra-reader agreement of expert radiologists on metastatic stage (M0 or M1)

• Treatments

  Therapies:

  Protein Inhibitor

  Medications:

  [18F] FAPI-74 ()

• Inclusion Criteria

  Key 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

  Key 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 > 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.

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