Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma

Summary

This is a prospective, multi-center, single arm, open label, non-randomized study to evaluate the ability of \[68Ga\]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The \[68Ga\]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second \[68Ga\]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection. This will be followed by histopathology and IHC analyses and comparison to resected PDAC tumor specimens.

Timeline

Start

2022-05-02

Primary completion

2025-03-07

Completion

2025-11-04

Publications

• Karbhari A, Mosessian S, Trivedi KH, Valla F Jr, Jacobson M, Truty MJ, Patnam NG, Simeone DM, Zan E, Brennan T, Chen H, Kuo PH, Herrmann K, Goenka AH. Gallium-68-labeled fibroblast activation protein inhibitor-46 PET in patients with resectable or borderline resectable pancreatic ductal adenocarcinoma: A phase 2, multicenter, single arm, open label non-randomized study protocol. PLoS One. 2023 Nov 27;18(11):e0294564. doi: 10.1371/journal.pone.0294564. eCollection 2023.

Drugs

Indications