NCT07217717 (FAPI-PRO) is a Phase 3 clinical trial of [18F]FAPI-74 PET/CT in Pancreatic Ductal Adenocarcinoma (PDAC), sponsored by SOFIE.

Who is sponsoring NCT07217717?

NCT07217717 is sponsored by SOFIE.

What drugs are being tested in NCT07217717?

Interventions in NCT07217717: [18F]FAPI-74 PET/CT.

What condition does NCT07217717 study?

NCT07217717 studies Pancreatic Ductal Adenocarcinoma (PDAC).

Is NCT07217717 still recruiting?

NCT07217717 is currently recruiting now. Last updated 16 March 2026.

Last reviewed 2026-03-16 · How we verify

NCT07217717: FAPI-PRO

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)

Recruiting now Phase 3 Last updated 16 March 2026

What this trial tests

Phase 3 trial testing [18F]FAPI-74 PET/CT in Pancreatic Ductal Adenocarcinoma (PDAC) in 200 participants. Currently enrolling.

Timeline

11 December 2025

Primary endpoint
31 December 2027

31 December 2027

Quick facts

Lead sponsor	SOFIE
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	200
Start date	11 December 2025
Primary completion	31 December 2027
Estimated completion	31 December 2027
Sites	10 locations across United States

Drugs / interventions tested

[18F]FAPI-74 PET/CT — full drug profile →

Conditions studied

Pancreatic Ductal Adenocarcinoma (PDAC) — all drugs for Pancreatic Ductal Adenocarcinoma (PDAC) →

Sponsor

SOFIE — full company profile →

Who can join

18 and older, any sex, with Pancreatic Ductal Adenocarcinoma (PDAC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Current status of FAP therapy in solid tumors.
Siegmund SC, Novruzov E, Mamlins E, Mori Y, et al · · 2026 · cited 1× · PMID 41455672 · DOI 10.1053/j.semnuclmed.2025.11.022

Verify or expand the search:

Other trials of [18F]FAPI-74 PET/CT

Trials testing the same drug.

NCT07217704 — Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer. · Phase 3 · recruiting
NCT05641896 — Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers · Phase 2 · completed

Other recruiting trials for Pancreatic Ductal Adenocarcinoma (PDAC)

Currently open trials in the same condition.

NCT07480928 — Dual-Targeting CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma · Phase 1, PHASE2 · recruiting
NCT07410494 — Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07030283 — Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis · Phase 1 · recruiting
NCT07235202 — A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarci · Phase 1, PHASE2 · recruiting
NCT06659705 — Cutting Edge Imaging With PET-FAPI for Earlier Pancreatic Cancer Diagnosis (INDIGO-FAPI) · Phase 2 · recruiting

Other SOFIE trials

Trials by the same sponsor.

NCT07217704 — Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer. · Phase 3 · recruiting
NCT05641896 — Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers · Phase 2 · completed
NCT05262855 — Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07217717 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by SOFIE
Last refreshed: 16 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07217717.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing