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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 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.

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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.

Conditions Studied

Pancreatic Ductal Adenocarcinoma (PDAC)

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

FieldValue
Enrollment Target 200 participants
Start Date 2025-12-11
Est. Completion 2027-12-31
Phase Phase 3

Sponsor

SOFIE

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07217717

The ClinicalTrials.gov registry entry for NCT07217717 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 284-participant average among 16 other Pancreatic Ductal Adenocarcinoma (PDAC) trials with a reported enrollment target (30% lower). The listed sponsor is SOFIE, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 10 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.