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

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ClinicalTrials.gov Identifier: NCT05262855
Recruitment Status : Recruiting
First Posted : March 2, 2022
Last Update Posted : August 28, 2023
Sponsor:
Information provided by (Responsible Party):
SOFIE

Study Description
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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.

Condition or disease Intervention/treatment Phase
PDAC - Pancreatic Ductal Adenocarcinoma FAP Drug: [68Ga]FAPI-46 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : May 2, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 68Ga-FAPI-46 PET/CT
Patients receive [68Ga]FAPI-46 intravenously followed by PET/CT 15-25 minutes later
 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).


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Histopathology with FAP staining on FAP IHC assay. [ Time Frame: Through study completion, 2 years ]
  3. 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 ]
  4. [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 ]
  5. [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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05262855


Contacts
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Contact: Sherly Mosessian, PH.D 818 324 1243 sherly.mosessian@sofie.com
Contact: Bridget Adams 319 430 1192 bridget.adams@sofie.com

Locations
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United States, California
University of California Los Angeles (UCLA) Health Recruiting
Los Angeles, California, United States, 90095
Contact: Aletta Deranteriassian       ADeranteriassian@mednet.ucla.edu   
Principal Investigator: Mark Girgis, M.D.         
Sub-Investigator: Jeremie Calais, M.D., M.Sc         
United States, Michigan
BAMF Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Clayton McNamara, RN    616-330-2735    Clayton.mcnamara@bamfhealth.com   
Principal Investigator: Harshad Kulkarni, M.D.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Maggie Olson, B.S.       Olson.Maggie@mayo.edu   
Principal Investigator: Ajit Goenka, MD         
Sub-Investigator: Geoffrey B Johnson, MD, PhD         
Sub-Investigator: Jay Thakkar, MD         
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Nadia Chowdhury       nadia.chowdhury@nyulangone.org   
Principal Investigator: Elcin Zan, MD         
Sub-Investigator: Diane Simeone, MD         
Sponsors and Collaborators
SOFIE
More Information
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Responsible Party: SOFIE
ClinicalTrials.gov Identifier: NCT05262855    
Other Study ID Numbers: GaFAPI-2022P2
First Posted: March 2, 2022    Key Record Dates
Last Update Posted: August 28, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SOFIE:
Fibroblast Activation Protein Inhibitor (FAPI)
PDAC
Additional relevant MeSH terms:
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Carcinoma, Ductal
Carcinoma, Pancreatic Ductal
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Pancreatic Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
FAPI-46
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action