68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma
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|ClinicalTrials.gov Identifier: NCT04457258|
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Sarcoma Recurrent Sarcoma Sarcoma||Procedure: Computed Tomography Drug: Gallium Ga 68 FAPi-46 Procedure: Positron Emission Tomography||Early 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 sarcoma with histopathology validation.
I. To evaluate whether 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET) reflects geography, extent and degree of FAP expression determined by immuno-histochemistry (IHC).
II. To assess the 68Ga-FAPI-46 biodistribution correlation with fludeoxyglucose F-18 (18F-FDG) biodistribution and to define the frequency of the following phenotypes (FAP positive [+]/ FDG+, FAP negative [-]/ FDG+, FAP+/ FDG-, FAP-/ FDG-).
Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Sarcoma: An Exploratory Biodistribution Study With Histopathology Validation|
|Actual Study Start Date :||September 8, 2020|
|Estimated Primary Completion Date :||July 1, 2023|
|Estimated Study Completion Date :||July 21, 2024|
Experimental: Diagnostic (68Ga-FAPI-46 PET/CT)
Patients receive 68Ga-FAPi-46 IV, and then undergo PET/CT over 20-90 minutes.
Procedure: Computed Tomography
Drug: Gallium Ga 68 FAPi-46
Procedure: Positron Emission Tomography
- Biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (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 and validated by FAP expression in surgically removed or biopsy derived tumor tissue.
- Frequency of the following phenotypes (FAP positive [+]/ fludeoxyglucose [FDG]+, FAP negative [-]/ FDG+, FAP+/ FDG-, FAP-/ FDG-) [ Time Frame: Up to year 2 ]Assessed by 68Ga-FAPI-46 biodistribution correlation with fludeoxyglucose F-18 (18F-FDG) biodistribution.
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): NCT04457258
|Contact: Soosan Roodbariemail@example.com|
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Soosan Roodbari 310-794-1596 firstname.lastname@example.org|
|Principal Investigator: Jeremie Calais, MD|
|Principal Investigator:||Jeremie Calais, MD||UCLA / Jonsson Comprehensive Cancer Center|