A Phase 1 interventional study of Computed Tomography and Gallium Ga 68 FAPi-46 in Bladder Carcinoma, Cervical Carcinoma and Cholangiocarcinoma, sponsored by Jonsson Comprehensive Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by Jonsson Comprehensive Cancer Center · Phase 1, Interventional, and Basic science
This exploratory study investigates how an imaging technique called 68Ga-FAPi-46 PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors (cancer associated fibroblasts). The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers.
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 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).
Patients with the following cancer types:
Exclusion Criteria:
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 · Drug: Gallium Ga 68 FAPi-46 · Procedure: Positron Emission Tomography · Radiation: 18F-FDG
Undergo PET/CT
Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Given IV
Also known as: 68Ga-FAPi-46, Gallium-68-FAPi-46
Undergo PET/CT
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Given IV
Also known as: 18F-fluorodeoxyglucose
Biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues
Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax).
Time frame: At 20-90 minutes after injection]
68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT)
Will be correlated with FAP expression in surgically removed or biopsy derived tumor tissue.
Time frame: Up to year 2
68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution
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-)
Time frame: up to 2 years
To assess the 68Ga-FAPI-46 biodistribution correlation with other PET tracers
The other PET tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax). The SUV of FAPI PET and the other PET tracers will be tested for correlation.
Time frame: 60 minutes after tracer injection
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Jonsson Comprehensive Cancer Center