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

Study Overview
=================
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.

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

Conditions
-----------------
PDAC - Pancreatic Ductal Adenocarcinoma, FAP

Intervention / Treatment
-----------------
* Drug: [68Ga]FAPI-46


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-FAPI-46 PET/CT<br>Patients receive [68Ga]FAPI-46 intravenously followed by PET/CT 15-25 minutes later | Drug: [68Ga]FAPI-46<br>* [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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Histopathology with FAP staining on FAP IHC assay. |  | Through study completion, 2 years | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |  | Up to 24 hours post injection with [68Ga]FAPI-46 | 
| [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 | 
| [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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibroblast Activation Protein Inhibitor (FAPI), PDAC