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68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04457258
Collaborator
National Cancer Institute (NCI) (NIH)
30
Enrollment
1
Location
1
Arm
46.4
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This early phase I trial studies an imaging technique called 68Ga-FAPi-46 PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with sarcoma. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-FAPi. Because some cancers take up 68Ga-FAPi it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Computed Tomography
  • Drug: Gallium Ga 68 FAPi-46
  • Procedure: Positron Emission Tomography
 Early Phase 1

Detailed Description

PRIMARY OBJECTIVE:
  1. To define the biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with sarcoma with histopathology validation.
SECONDARY OBJECTIVES:

  1. To evaluate whether 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET) reflects geography, extent and degree of FAP expression determined by immuno-histochemistry (IHC).

  2. To assess the 68Ga-FAPI-46 biodistribution correlation with fludeoxyglucose F-18 (18F-FDG) biodistribution and to define the frequency of the following phenotypes (FAP positive [+]/ FDG+, FAP negative [-]/ FDG+, FAP+/ FDG-, FAP-/ FDG-).

OUTLINE:

Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Sarcoma: An Exploratory Biodistribution Study With Histopathology Validation
Actual Study Start Date :
Sep 8, 2020
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 21, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostic (68Ga-FAPI-46 PET/CT)

Patients receive 68Ga-FAPi-46 IV, and then undergo PET/CT over 20-90 minutes.

Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

    • Drug: Gallium Ga 68 FAPi-46
    Given IV
    Other Names:
  • 68Ga-FAPi-46
  • Gallium-68-FAPi-46

    • Procedure: Positron Emission Tomography
    Undergo PET/CT
    Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues [At 20-90 minutes after injection]

      Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax).

    Secondary Outcome Measures

    1. 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT) [Up to year 2]

      Will be correlated with and validated by FAP expression in surgically removed or biopsy derived tumor tissue.

    2. Frequency of the following phenotypes (FAP positive [+]/ fludeoxyglucose [FDG]+, FAP negative [-]/ FDG+, FAP+/ FDG-, FAP-/ FDG-) [Up to year 2]

      Assessed by 68Ga-FAPI-46 biodistribution correlation with fludeoxyglucose F-18 (18F-FDG) biodistribution.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients who underwent a 18F-FDG PET/CT scan within 3 months of enrollment.

    • Patients who are scheduled to undergo surgical excision or biopsy of a sarcoma primary, recurrent or metastatic lesion.

    • Patients who can provide written informed consent.

    • Patients who are able to remain still for duration of imaging procedure (up to one hour).

    Exclusion Criteria:
    • Patients with any new sarcoma therapy between the 18F-FDG PET/CT and the FAPI PET/CT.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA / Jonsson Comprehensive Cancer Center Los Angeles California United States 90095

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Jeremie Calais, MD, UCLA / Jonsson Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonsson Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04457258
    Other Study ID Numbers:
    • 20-000623
    • NCI-2020-03767
    • 20-000623
    First Posted:
    Jul 7, 2020
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Sarcoma
    FAPI-46

    Study Results

    No Results Posted as of Apr 4, 2022