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NCT07217704 · ClinicalTrials.gov registry record · Phase 3
Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.
A Phase 3 study of Esophageal Cancer and Gastroesophageal Junction, sponsored by SOFIE.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 10
- Study locations
NCT07217704 is a Phase 3 study of Esophageal Cancer and Gastroesophageal Junction that is actively recruiting participants, run by SOFIE. The registered enrollment target is 200 participants, below the 497-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (60% lower). The trial reports 10 study locations across 6 states.
The verdict
NCT07217704, a Phase 3 study of Esophageal Cancer and Gastroesophageal Junction, is actively recruiting participants, sponsored by SOFIE.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 10
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG [18F]FAPI-74 PET/CT
Study Locations (10)
California
- Helios CR Inc./RadNet - Cerritos
- Hoag Memorial Hospital - Irvine
- UCLA - Los Angeles
Massachusetts
- Massachusetts General Hospital - Boston
- UMass/Shields - Worcester
Ohio
- Cleveland Clinic - Cleveland
- Kettering - Kettering
Florida
- Moffit Cancer Center - Tampa
Indiana
- Indiana University Health University Hospital - Indianapolis
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-11-14 |
| Est. Completion | 2027-08-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07217704
The ClinicalTrials.gov registry entry for NCT07217704 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 497-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (60% lower). The listed sponsor is SOFIE, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Esophageal Cancer appearing as the primary indexed condition, and to 1 intervention - of which [18F]FAPI-74 PET/CT is the first listed.
NCT07217704 reports 10 study locations spanning 6 distinct geographic areas - top geographies include California, Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT07217704 about?
NCT07217704 is a clinical study titled "Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.". 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 standa...
What is the current status of trial NCT07217704?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2025-11-14. Estimated completion is 2027-08-30.
What conditions does trial NCT07217704 study?
This clinical trial studies the following conditions: Esophageal Cancer, Gastroesophageal Junction, Gastric Cancer (GC).
What interventions are being tested in trial NCT07217704?
The interventions under investigation include: [18F]FAPI-74 PET/CT (DRUG).
Who is sponsoring clinical trial NCT07217704?
This trial is sponsored by SOFIE, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07217704 being conducted?
This trial has 10 study locations across California, Florida, Indiana, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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