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

NCT ID: NCT05262855

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-02
• Study Completion Date: 2025-11-04

Brief 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.

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma; FAP

Keywords

Fibroblast Activation Protein Inhibitor (FAPI); PDAC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-FAPI-46 PET/CT

Patients receive \[68Ga\]FAPI-46 intravenously followed by PET/CT 15-25 minutes later

Group Type: EXPERIMENTAL

[68Ga]FAPI-46

Intervention Type: DRUG

\[68Ga\]-FAPI-46 is a radioactive diagnostic agent indicated for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) in patients with pancreatic ductal adenocarcinoma (PDAC).

Interventions

[68Ga]FAPI-46

\[68Ga\]-FAPI-46 is a radioactive diagnostic agent indicated for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) in patients with pancreatic ductal adenocarcinoma (PDAC).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Pathologically confirmed pancreatic ductal adenocarcinoma

2. Treatment-naïve

3. Staged as resectable or borderline-resectable

4. Planned to undergo surgical resection or to receive neoadjuvant therapy (i.e., chemotherapy, radiation therapy, or combination) and subsequent possible surgical resection

5. Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent

6. Age ≥ 18 years

7. Completed informed consent as determined per the IRB of record

Exclusion Criteria

1. Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential

2. Declining to use effective contraceptive methods during the study (for individuals of child-producing potential)

3. Need for emergent surgery that would be delayed by participation

4. Bacterial, viral, or fungal infections requiring systemic therapy

5. Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator, physician of record and/or Sofie could compromise patient safety and/or protocol objectives.

6. Known diagnosis of autoimmune disorders

7. Patients receiving any other investigational agent within the past 28 days

8. Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the [68Ga]FAPI-46 injection.

9. Known hypersensitivity to any excipients used in [68Ga]FAPI-46:

trace amounts of sodium acetate sodium ascorbate and/or hydrochloric acid

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SOFIE

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California Los Angeles (UCLA) Health

Los Angeles, California, United States

BAMF Health

Grand Rapids, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

NYU Langone Health

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38011131 (View on PubMed)

Other Identifiers

GaFAPI-2022P2

Identifier Type: -

Identifier Source: org_study_id