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

NCT05262855 | Completed Phase 2 Results FDA Drug

• 1 other identifier: GaFAPI-2022P2
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity of [68Ga]FAPI-46 PET Imaging to Detect PDAC, Using Histopathology as Truth Standard

  Sensitivity was defined as the proportion of participants with histopathology-confirmed PDAC who had a positive \[⁶⁸Ga\]FAPI-46 PET result for the primary lesion. Sensitivity was calculated by comparing positive and negative \[⁶⁸Ga\]FAPI-46 PET findings with the corresponding histopathology results, using a single readable PET image matched to its reference histopathology assessment. Sensitivity was calculated as A / (A + C), where A represents true-positive findings and C represents false-negative findings. Higher sensitivity indicates a greater ability of \[⁶⁸Ga\]FAPI-46 PET to detect FAP-expressing disease and a lower likelihood of false-negative results, thereby reflecting the effectiveness of the imaging modality relative to the histopathological reference standard.

  Day 1

Secondary Outcomes (4)

• Correlation Between [⁶⁸Ga]FAPI-46 PET Uptake (SUVmax) and IHC Staining Intensity (H-score) in FAP-positive Lesions

  Day 1

• Sensitivity of [68Ga]FAPI-46 PET to Detect FAP-expressing Cells Using H-score as Standard of Truth

  Day 1

• Specificity of [68Ga]FAPI-46 PET to Detect FAP-expressing Cells Using H-score as Standard of Truth

  Day 1

• Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

  Up to 2 years

Study Arms (1)

68Ga-FAPI-46 PET/CT

EXPERIMENTAL

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

Drug: [68Ga]FAPI-46

Interventions

[68Ga]FAPI-46 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).

68Ga-FAPI-46 PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed pancreatic ductal adenocarcinoma
• Treatment-naïve
• Staged as resectable or borderline-resectable
• Planned to undergo surgical resection or to receive neoadjuvant therapy (i.e., chemotherapy, radiation therapy, or combination) and subsequent possible surgical resection
• Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent
• Age ≥ 18 years
• Completed informed consent as determined per the IRB of record

You may not qualify if:

• Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential
• Declining to use effective contraceptive methods during the study (for individuals of child-producing potential)
• Need for emergent surgery that would be delayed by participation
• Bacterial, viral, or fungal infections requiring systemic therapy
• 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.
• Known diagnosis of autoimmune disorders
• Patients receiving any other investigational agent within the past 28 days
• 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.
• Known hypersensitivity to any excipients used in \[68Ga\]FAPI-46:
• trace amounts of sodium acetate sodium ascorbate and/or hydrochloric acid

Sponsors & Collaborators

• SOFIE: lead

Study Sites (4)

University of California Los Angeles (UCLA) Health

Los Angeles, California, 90095, United States

Location

BAMF Health

Grand Rapids, Michigan, 49503, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 38011131 DERIVED

MeSH Terms

Interventions

FAPI-46

Results Point of Contact

• Title: Bridget Adams, Director of Clinical Operations
• Organization: Sofie Biosciences, Inc

bridget.adams@sofie.com

+319 421-8448

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 2, 2022
• Study Start: May 2, 2022
• Primary Completion: March 7, 2025
• Study Completion: November 4, 2025
• Last Updated: May 29, 2026
• Results First Posted: May 29, 2026

Record last verified: 2026-05

Locations

US (4)