18F-FAPI PET/CT to find spread of stomach or esophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-site, open-label, non-randomized Phase 3 imaging protocol administers a single dose of [18F]FAPI-74 followed by PET/CT using a standardized procedure. Adults with pathologically confirmed gastric, gastroesophageal junction, or esophageal cancer undergo the PET/CT and their standard-of-care procedures are captured for about three months to compare imaging findings. The primary outcome is the sensitivity and specificity of [18F]FAPI-74 PET/CT for detecting metastatic disease using a composite standard-of-truth panel. Safety follow-up occurs for 24 to 72 hours after the scan and the program is expected to run about 24 months from first patient screening to last SOC follow-up.

Why it matters

Who can join: the full rules

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

Where it's running

• Helios CR Inc./RadNet
  Cerritos, California, United States Recruiting
• City of Hope National Cancer Center
  Duarte, California, United States Recruiting
• Hoag Memorial Hospital
  Irvine, California, United States Recruiting
• UCLA
  Los Angeles, California, United States Recruiting
• Stanford University
  Stanford, California, United States Recruiting
• Impression Imaging
  Coral Springs, Florida, United States Recruiting

Study contacts

• Study coordinator: Alex Osipova
• Email: Alex.osipova@sofie.com
• Phone: 1-800-753-5368

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.