68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma
NCT ID: NCT04457258
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
EARLY_PHASE1
18 participants
INTERVENTIONAL
2020-09-08
2027-07-21
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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).
Computed Tomography
Undergo PET/CT
Gallium Ga 68 FAPi-46
Given IV
Positron Emission Tomography
Undergo PET/CT
18F-FDG
Given IV
Interventions
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Computed Tomography
Undergo PET/CT
Gallium Ga 68 FAPi-46
Given IV
Positron Emission Tomography
Undergo PET/CT
18F-FDG
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jeremie Calais, MD
Role: PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Locations
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2020-03767
Identifier Type: REGISTRY
Identifier Source: secondary_id
20-000623
Identifier Type: OTHER
Identifier Source: secondary_id
20-000623
Identifier Type: -
Identifier Source: org_study_id
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