Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
NCT ID: NCT04459273
Last Updated: 2025-09-09
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
26 participants
INTERVENTIONAL
2020-08-27
2027-07-01
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 various malignancies.
SECONDARY OBJECTIVES:
I. To evaluate the degree of 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET) imaging as opposed to the amount of FAP in excised cancer tissue.
II. 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-)
EXPERIMENTAL OBJECTIVE:
To assess the correlation of 68Ga-FAPI-46 biodistribution with 68Ga-DOTATATE or 18F-DOPA (FDOPA), depending on the specific indication in patients who had them available
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
BASIC_SCIENCE
NONE
Study Groups
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Basic science (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
* Brain cancer
* Bladder cancer
* Urothelial cancer
* Testicular cancer
* Skin cancer
* Thyroid cancer
* Hepatocellular carcinoma
* Cholangiocarcinoma
* Thymus cancer
* Pleural cancer
* Cervical cancer
* Adrenal cancer
* Neuroendocrine tumors
* Hematologic cancer
* Cancer of Unkown Primary
* Patients who are scheduled to undergo surgical resection or tissue biopsy of the primary tumor and/or metastasis
* Patients are ≥ 18 years old at the time of the radiotracer administration.
* Patient can provide written informed consent
* Patient is able to remain still for duration of imaging procedure (up to one hour)
Exclusion Criteria
* Patients with any new cancer therapy between the baseline 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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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-2020-03766
Identifier Type: REGISTRY
Identifier Source: secondary_id
20-000630
Identifier Type: -
Identifier Source: org_study_id
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