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

ID#: NCT07217704

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: November 14, 2025

End Date: August 30, 2027

Contact Information:
Alex Osipova
1-800-753-5368
Bridget Adams
1-800-753-5368
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 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.
Eligibility:

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
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