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.
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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

Alex Osipova

1-800-753-5368

Alex.osipova@sofie.com

CONTACT

Bridget Adams

1-800-753-5368

bridget.adams@sofie.com

CONTACT