Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)
Recruiting
Phase 3
Interventional Study
Pancreatic Ductal Adenocarcinoma (PDAC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 200 (estimated)
- Sponsor
- SOFIE · Industry
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About This Trial
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 inte…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Male and female adults ≥ 18 years.
* Participants with confirmed PDAC, undergoing staging evaluation for treatment planning.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2:
* Provided signed, written informed consent obtained prior to any study-related proce…
Contacts