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

Primary Purpose

PDAC - Pancreatic Ductal Adenocarcinoma, FAP

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

[68Ga]FAPI-46

About this trial

This is an interventional diagnostic trial for PDAC - Pancreatic Ductal Adenocarcinoma focused on measuring Fibroblast Activation Protein Inhibitor (FAPI), PDAC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

University of California Los Angeles (UCLA) HealthRecruiting
BAMF HealthRecruiting
Mayo ClinicRecruiting
NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-FAPI-46 PET/CT

Arm Description

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

Outcomes

Primary Outcome Measures

Performance [sensitivity, specificity, accuracy] of [68Ga]FAPI-46 PET imaging to detect FAP-expressing cells, using histopathology as truth standard.

Secondary Outcome Measures

Positive and negative predictive values, as well as accuracy of [68Ga]FAPI-46 PET images, to detect FAP-expressing cells using histopathology as truth standard.

Histopathology with FAP staining on FAP IHC assay.

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

[68Ga]FAPI-46 accumulation observed in local and metastatic disease compared to radiological (i.e. CT, MR) and/or 18F-FDG PET.

[68Ga]FAPI-46 accumulation observed by (PET)/ (CT) pre and post in patients undergoing Neoadjuvant treatment.

Full Information

NCT ID

NCT05262855

First Posted

February 10, 2022

Last Updated

August 25, 2023

Sponsor

SOFIE

1. Study Identification

Unique Protocol Identification Number

NCT05262855

Brief Title

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

Acronym

FAPI-46 PDAC

Official Title

A Phase 2, Multicenter, Single Arm, Open Label Non-Randomized Study of [68Ga]FAPI-46 PET in Patients With Resectable or Borderline Resectable Pancreatic Ductal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 2, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SOFIE

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PDAC - Pancreatic Ductal Adenocarcinoma, FAP

Keywords

Fibroblast Activation Protein Inhibitor (FAPI), PDAC

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

68Ga-FAPI-46 PET/CT

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

[68Ga]FAPI-46

Intervention Description

[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).

Primary Outcome Measure Information:

Title

Performance [sensitivity, specificity, accuracy] of [68Ga]FAPI-46 PET imaging to detect FAP-expressing cells, using histopathology as truth standard.

Time Frame

Through study completion, 2 years

Secondary Outcome Measure Information:

Title

Positive and negative predictive values, as well as accuracy of [68Ga]FAPI-46 PET images, to detect FAP-expressing cells using histopathology as truth standard.

Time Frame

Through study completion, 2 years

Title

Histopathology with FAP staining on FAP IHC assay.

Time Frame

Through study completion, 2 years

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time Frame

Up to 24 hours post injection with [68Ga]FAPI-46

Title

[68Ga]FAPI-46 accumulation observed in local and metastatic disease compared to radiological (i.e. CT, MR) and/or 18F-FDG PET.

Time Frame

Through study completion, 2 years

Title

[68Ga]FAPI-46 accumulation observed by (PET)/ (CT) pre and post in patients undergoing Neoadjuvant treatment.

Time Frame

Through study completion for patient undergoing Neoadjuvant treatment, 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sherly Mosessian, PH.D

Phone

818 324 1243

sherly.mosessian@sofie.com

First Name & Middle Initial & Last Name or Official Title & Degree

Bridget Adams

Phone

319 430 1192

bridget.adams@sofie.com

Facility Information:

Facility Name

University of California Los Angeles (UCLA) Health

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aletta Deranteriassian

ADeranteriassian@mednet.ucla.edu

First Name & Middle Initial & Last Name & Degree

Mark Girgis, M.D.

First Name & Middle Initial & Last Name & Degree

Jeremie Calais, M.D., M.Sc

Facility Name

BAMF Health

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clayton McNamara, RN

Phone

616-330-2735

Clayton.mcnamara@bamfhealth.com

First Name & Middle Initial & Last Name & Degree

Harshad Kulkarni, M.D.

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maggie Olson, B.S.

Olson.Maggie@mayo.edu

First Name & Middle Initial & Last Name & Degree

Ajit Goenka, MD

First Name & Middle Initial & Last Name & Degree

Geoffrey B Johnson, MD, PhD

First Name & Middle Initial & Last Name & Degree

Jay Thakkar, MD

Facility Name

NYU Langone Health

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nadia Chowdhury

nadia.chowdhury@nyulangone.org

First Name & Middle Initial & Last Name & Degree

Elcin Zan, MD

First Name & Middle Initial & Last Name & Degree

Diane Simeone, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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