What is the purpose of this study?
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
- 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.
- 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 can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
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
- Disease Type/ConditionGastric Cancer, Esophageal Cancer
- Principal InvestigatorGary Ulaner, MD
- Co-InvestigatorsRyan P. Reddy, MD
- Age GroupAdult, Older Adult
- PhaseIII
- ClinicalTrials.gov IDNCT07217704
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Beth Thomsen
Beth.thomsen@hoag.org
Hoag Family Cancer Institute
Hoag Family Cancer Institute delivers advanced, compassionate cancer care across Orange County, with multidisciplinary specialists, precision therapies, support services, and access to 125+ cancer clinical trials. Patients benefit from research-driven care across a wide range of cancers, including breast, lung, gynecologic, prostate, gastrointestinal, and blood cancers.
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