Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.

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 Gastric or Esophageal Cancer

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 gastric, gastroesophageal junction or esophageal cancer. 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 gastric or esophageal cancers.

Primary outcome measures

• Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference [Time frame: From enrollment to the end of treatment after 3 month follow up]

Secondary outcome measures (8)

• Incidence and severity of adverse events using CTCAE v5. [Time frame: 24-72 hours post-injection]
• Sensitivity and specificity for the localized detection of peritoneal metastases [Time frame: From enrollment to the end of treatment after 3 month follow up]
• Comparative sensitivity and specificity between [18F]FAPI-74 and [¹⁸F]FDG PET/CT for detection of M1 disease using a composite SOT as reference [Time frame: From enrollment to the end of treatment after 3 month follow up]
• 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: 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 gastric, esophageal or gastroesophageal malignancy undergoing staging evaluation for treatment planning.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• Provided signed, written informed consent 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 diagnostic or therapeutic 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 (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 currently 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, ulcerative colitis)
• Sarcoidosis
• Treatment, including chemotherapy, radiation, immunotherapy or surgery for curative intent of Gastroesophageal cancers

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: NCT07217704 · 18FFAPI-2025P3-GEC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗