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

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ClinicalTrials.gov Identifier: NCT04457258
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : January 10, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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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
Metastatic Sarcoma Recurrent Sarcoma Sarcoma Procedure: Computed Tomography Drug: Gallium Ga 68 FAPi-46 Procedure: Positron Emission Tomography Radiation: 18F-FDG Early Phase 1

Detailed Description:

PRIMARY OBJECTIVE:

I. 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:

I. 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).

II. 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-).

III. 3. To determine FAP expression profile and identify activating and loss of function mutations and gene rearrangement in available tumor tissue samples from patients with localized or metastatic sarcoma using RNA sequencing

OUTLINE:

Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 8, 2020
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 21, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Diagnostic (68Ga-FAPI-46 PET/CT)
Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).
 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

Radiation: 18F-FDG
Given IV
Other Name: 18F-fluorodeoxyglucose


Outcome Measures
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Primary Outcome Measures :
  1. Biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues [ Time Frame: 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) [ Time Frame: 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-) [ Time Frame: Up to year 2 ]
    To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-)


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:

  • Patients who are scheduled to undergo surgical excision or biopsy of a suspected sarcoma primary, or a suspected recurrent or metastatic lesion.
  • Patients who are ≥ 18 years old at the time of the radiotracer administration.
  • Patients who can provide written informed consent.
  • Patients who are able to remain still for duration of imaging procedures (up to one hour for each).

Exclusion Criteria:

  • Patient is pregnant or nursing.
  • Patients with any new cancer therapy between the baseline 18F-FDG PET/CT and the investigational FAPI PET/CT
  • Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high quality data.
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): NCT04457258


Contacts
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Contact: Andrea Limon 310-206-7372 AndreaLimon@mednet.ucla.edu
Contact: Rejah Marie Alano 310-206-7372 RMAlano@mednet.ucla.edu

Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Andrea Limon    310-206-7372    AndreaLimon@mednet.ucla.edu   
Contact: Rejah Marie Alano    310-206-7372    RMAlano@mednet.ucla.edu   
Principal Investigator: Jeremie Calais, MD         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jeremie Calais, MD UCLA / Jonsson Comprehensive Cancer Center
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04457258    
Other Study ID Numbers: 20-000623
NCI-2020-03767 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
20-000623 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: January 10, 2023
Last Verified: April 2022

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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:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
 Fluorodeoxyglucose F18
FAPI-46
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action