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NCT07217717 · ClinicalTrials.gov registry record · Phase 3
Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)
A Phase 3 study of Pancreatic Ductal Adenocarcinoma (PDAC), sponsored by SOFIE.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 10
- Study locations
NCT07217717: Recruiting Phase 3 study of Pancreatic Ductal Adenocarcinoma (PDAC), sponsored by SOFIE.
NCT07217717 is a Phase 3 study of Pancreatic Ductal Adenocarcinoma (PDAC) that is actively recruiting participants, run by SOFIE. The registered enrollment target is 200 participants, below the 284-participant average among 16 other Pancreatic Ductal Adenocarcinoma (PDAC) trials with a reported enrollment target (30% lower). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07217717, a Phase 3 study of Pancreatic Ductal Adenocarcinoma (PDAC), 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 pancreatic ductal adenocarcinoma. 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.
Primary Outcome
To evaluate the diagnostic performance of \[¹⁸F\]FAPI-74 PET/CT scan in determining the presence or absence of metastatic disease (M1) in patients with pancreatic ductal adenocarcinoma compared with a composite standard of truth (SOT).
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 | 2025-12-11 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 3 |
What NCT07217717 shows while recruiting
NCT07217717 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 284-participant average among 16 other Pancreatic Ductal Adenocarcinoma (PDAC) trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Pancreatic Ductal Adenocarcinoma (PDAC) appearing as the primary indexed condition, and to 1 intervention - of which [18F]FAPI-74 PET/CT is the first listed.
NCT07217717 lists 10 locations in 6 states (California, Massachusetts, Ohio).
Frequently Asked Questions
What is clinical trial NCT07217717 about?
NCT07217717 is a clinical study titled "Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)". 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 pancreatic ductal adenocarcinoma. Following screening, using a standardized administration p...
What is the current status of trial NCT07217717?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2025-12-11. Estimated completion is 2027-12-31.
What conditions does trial NCT07217717 study?
This clinical trial studies the following conditions: Pancreatic Ductal Adenocarcinoma (PDAC).
What interventions are being tested in trial NCT07217717?
The interventions under investigation include: [18F]FAPI-74 PET/CT (DRUG).
Who is sponsoring clinical trial NCT07217717?
This trial is sponsored by SOFIE, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07217717 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.
Learn More About Clinical Trials
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Where NCT07217717's enrollment target sits among peer trials
200 9th of 16 higher than 7 of 16 other Pancreatic Ductal Adenocarcinoma (PDAC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Ductal Adenocarcinoma (PDAC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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