Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer. (NCT07217704)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Helios CR Inc./RadNet — Cerritos, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- Helios CR Inc./RadNet — Cerritos, California
- City of Hope National Cancer Center — Duarte, California
- Hoag Memorial Hospital — Irvine, California
- UCLA — Los Angeles, California
- Stanford University — Stanford, California
- Moffit Cancer Center — Tampa, Florida
- Indiana University Health University Hospital — Indianapolis, Indiana
- Massachusetts General Hospital — Boston, Massachusetts
- UMass/Shields — Worcester, Massachusetts
- Mayo Clinic Rochester — Rochester, Minnesota
- Icahn School of Medicine at Mount Sinai — New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Cleveland Clinic — Cleveland, Ohio
- Kettering — Kettering, Ohio
- University of Pennsylvania, Perelman School of Medicine — Philadelphia, Pennsylvania
📞 Contact the Study Coordinator
Phone: (800) 753-5368
Email: Alex.osipova@sofie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.