Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers (FAPI PET RDRC)
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|ClinicalTrials.gov Identifier: NCT04459273|
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : April 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|Bladder Carcinoma Cervical Carcinoma Cholangiocarcinoma Hematopoietic and Lymphoid Cell Neoplasm Hepatocellular Carcinoma Malignant Adrenal Gland Neoplasm Malignant Brain Neoplasm Malignant Pleural Neoplasm Malignant Skin Neoplasm Malignant Solid Neoplasm Malignant Testicular Neoplasm Malignant Thymus Neoplasm Neuroendocrine Neoplasm Thyroid Gland Carcinoma Urothelial Carcinoma||Procedure: Computed Tomography Drug: Gallium Ga 68 FAPi-46 Procedure: Positron Emission Tomography||Phase 1|
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.
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 correlation of 68Ga-FAPI-46 biodistribution with 18F-fluodeoxyglucose (FDG), 68Ga-DOTATATE, or 18F-DOPA (FDOPA), depending on the specific indication.
Patients receive 68Ga-FAPi-46 intravenously (IV) then 20-90 minutes later undergo PET/computed tomography (CT).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: An Exploratory Biodistribution Study With Histopathology Validation|
|Actual Study Start Date :||August 27, 2020|
|Estimated Primary Completion Date :||July 1, 2023|
|Estimated Study Completion Date :||July 1, 2024|
Experimental: Basic science (68GA-FAPI-46 PET/CT)
Patients receive 68Ga-FAPi-46 IV then 20-90 minutes later undergo PET/CT.
Procedure: Computed Tomography
Drug: Gallium Ga 68 FAPi-46
Procedure: Positron Emission Tomography
- Biodistribution of gallium 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).
- 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT) [ Time Frame: Up to year 2 ]Will be correlated with FAP expression in surgically removed or biopsy derived tumor tissue.
- To assess the 68Ga-FAPI-46 biodistribution correlation with other PET tracers [ Time Frame: 60 minutes after tracer injection ]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.
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): NCT04459273
|Contact: Erin Shenfirstname.lastname@example.org|
|Contact: Stephanie Lira||310-206-0596||StephanieLira@mednet.ucla.edu|
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Erin Shen 310-206-7372 email@example.com|
|Contact: Stepanie Lira 310-206-0596 StephanieLira@mednet.ucla.edu|
|Principal Investigator: Jeremie Calais|
|Principal Investigator:||Jeremie Calais||UCLA / Jonsson Comprehensive Cancer Center|