Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04147494|
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : July 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Carcinoma Colon Carcinoma Esophageal Carcinoma Gastric Carcinoma Head and Neck Carcinoma Kidney Carcinoma Lung Carcinoma Ovarian Carcinoma Pancreatic Carcinoma Solid Neoplasm Uterine Corpus Cancer||Procedure: Computed Tomography Radiation: Gallium Ga 68 FAPi-46 Radiation: Gallium Ga 68-labeled PSMA-11 Procedure: Positron Emission Tomography||Early Phase 1|
I. To define the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) in normal and cancer tissues of patients with various non-prostate malignancies. The goal is to determine where and to which degree 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulates in normal and cancer tissues.
I. To evaluate whether 68Ga-FAPi-46 and 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. As an exploratory study aim, will also assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11, if the patient volunteers for optional scan, and 18F-fluodeoxyglucose (FDG), if any FDG PET/computed tomography (CT) has been performed as standard-of-care.
Patients receive 68Ga-FAPi-46 intravenously (IV) and undergo PET/CT scan over 20-50 minutes. Patients may also receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 20-50 minutes on a separate day (for volunteer patients only, PSMA PET/CT is optional and not required).
|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-PSMA-11 and 68Ga-FAPI-46 in Patients With Non-Prostate Cancers: An Exploratory Biodistribution Study With Histopathology Validation|
|Actual Study Start Date :||November 5, 2019|
|Estimated Primary Completion Date :||June 1, 2030|
|Estimated Study Completion Date :||October 17, 2031|
Experimental: Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT)
Patients receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes. Patients may also receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 20-50 minutes on a separate day (for volunteer patients only, PSMA PET/CT is optional and not required).
Procedure: Computed Tomography
Undergo PET/CT scan
Radiation: Gallium Ga 68 FAPi-46
Radiation: Gallium Ga 68-labeled PSMA-11
Procedure: Positron Emission Tomography
Undergo PET/CT scan
- To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) in normal and cancer tissues of patients with various non-prostate malignancies [ Time Frame: 60 minutes after tracer injection ]To quantify tumor tissue and normal background organs positron emission tomography (PET) tracer uptake by semi-quantitative analysis (unit/metrics = standardized uptake values (SUV)). The 68Ga-PSMA-11 and 68Ga-FAPI-46 tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax).
- 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulation [ Time Frame: From date of imaging to date of surgery (range 1-60 days) ]To correlate PET imaging signal with fibroblast activation protein (FAP) and prostate specific membrane antigen (PSMA) expression by immunohistochemistry (IHC). 68Ga-FAPi-46 and 68Ga-PSMA tumor SUVs will be correlated with FAP and PSMA expression from surgically resected tumors. IHC will be scored with a semi-quantitative scoring system that accounts for staining intensity (0-2, where 0 is negative, 1 is weak, 2 is strong and eq. stands for equivocal). Correlations will be sought using least square regression analysis.
- Additional correlation of biodistribution of standard of care tracer [ Time Frame: 60 minutes after tracer injection ]68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11 and 18F-fluodeoxyglucose (FDG), if any FDG PET/CT has been performed as standard-of-care.
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): NCT04147494
|Contact: Stephanie Lira||310 206-7372||StephanieLira@mednet.ucla.edu|
|Contact: Rejah Alano||310 206-7372||RMAlano@mednet.ucla.edu|
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Kiara Booker Adame 310-206-7372 KMBooker@mednet.ucla.edu|
|Contact: Stephanie Lira 310 206-7372 StephanieLira@mednet.ucla.edu|
|Principal Investigator: Jeremie Calais, MD|
|Principal Investigator:||Jeremie Calais, MD||UCLA / Jonsson Comprehensive Cancer Center|