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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 : May 2, 2024
Sponsor:
Information provided by (Responsible Party):
SOFIE

Tracking Information
First Submitted Date  ICMJE February 10, 2022
First Posted Date  ICMJE March 2, 2022
Last Update Posted Date May 2, 2024
Actual Study Start Date  ICMJE May 2, 2022
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2022)		 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2022)
  • 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 ]
  • Histopathology with FAP staining on FAP IHC assay. [ Time Frame: Through study completion, 2 years ]
  • 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 ]
  • [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 ]
  • [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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • PDAC - Pancreatic Ductal Adenocarcinoma
  • FAP
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: 68Ga-FAPI-46 PET/CT
Patients receive [68Ga]FAPI-46 intravenously followed by PET/CT 15-25 minutes later
Intervention: Drug: [68Ga]FAPI-46
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 21, 2022)		 60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sherly Mosessian, PH.D 818 324 1243 sherly.mosessian@sofie.com
Contact: Bridget Adams 319 430 1192 bridget.adams@sofie.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05262855
Other Study ID Numbers  ICMJE GaFAPI-2022P2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party SOFIE
Original Responsible Party Same as current
Current Study Sponsor  ICMJE SOFIE
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SOFIE
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP