Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation
NCT ID: NCT04457232
Last Updated: 2025-07-15
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
PHASE1
30 participants
INTERVENTIONAL
2020-09-09
2026-05-30
Brief Summary
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Detailed Description
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I. To define the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer.
SECONDARY OBJECTIVES:
I. To evaluate whether 68Ga-FAPi-46 and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) accumulation observed by positron emission tomography (PET) correlates with the amount of fibroblast activation protein (FAP) and prostate specific membrane antigen (PSMA) in excised cancer tissue, respectively.
II. To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11.
OUTLINE:
Patients receive 68Ga-FAPi-46 intravenously (IV) and undergo PET/computed tomography (CT) imaging over 20-50 minutes.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Basic Science (68Ga-FAPi-46 PET/CT)
Patients receive 68Ga-FAPi-46 IV and undergo PET/CT imaging over 20-50 minutes.
Computed Tomography
Undergo PET/CT imaging
Gallium Ga 68 FAPi-46
Given IV
Positron Emission Tomography
Undergo PET/CT imaging
Interventions
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Computed Tomography
Undergo PET/CT imaging
Gallium Ga 68 FAPi-46
Given IV
Positron Emission Tomography
Undergo PET/CT imaging
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who are scheduled to undergo surgical excision or biopsy of a prostate cancer primary, recurrent or metastatic lesion
* Patients can provide written informed consent
* Patients are able to remain still for duration of imaging procedure (up to one hour)
Exclusion Criteria
18 Years
MALE
No
Sponsors
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Prostate Cancer Foundation
OTHER
Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jeremie Calais
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-2020-02712
Identifier Type: REGISTRY
Identifier Source: secondary_id
20-000177
Identifier Type: OTHER
Identifier Source: secondary_id
20-000177
Identifier Type: -
Identifier Source: org_study_id
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