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

PDAC - Pancreatic Ductal Adenocarcinoma Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05262855
• Other study ID #: GaFAPI-2022P2
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: SOFIE
• Contact: Sherly Mosessian, PH.D
• Phone: 818 324 1243
• Email: sherly.mosessian[@]sofie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ductal
• Carcinoma, Pancreatic Ductal
• FAP
• PDAC - Pancreatic Ductal Adenocarcinoma

Intervention

Drug:
• [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).

Locations

Country	Name	City	State
United States	BAMF Health	Grand Rapids	Michigan
United States	University of California Los Angeles (UCLA) Health	Los Angeles	California
United States	NYU Langone Health	New York	New York
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
SOFIE

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance [sensitivity, specificity, accuracy] of [68Ga]FAPI-46 PET imaging to detect FAP-expressing cells, using histopathology as truth standard.		Through study completion, 2 years
Secondary	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.		Through study completion, 2 years
Secondary	Histopathology with FAP staining on FAP IHC assay.		Through study completion, 2 years
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0		Up to 24 hours post injection with [68Ga]FAPI-46
Secondary	[68Ga]FAPI-46 accumulation observed in local and metastatic disease compared to radiological (i.e. CT, MR) and/or 18F-FDG PET.		Through study completion, 2 years
Secondary	[68Ga]FAPI-46 accumulation observed by (PET)/ (CT) pre and post in patients undergoing Neoadjuvant treatment.		Through study completion for patient undergoing Neoadjuvant treatment, 2 years