18F-Clofarabine PET/CT in Imaging Cancer Patients Before and After Interventions
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|ClinicalTrials.gov Identifier: NCT02888301|
Recruitment Status : Recruiting
First Posted : September 5, 2016
Last Update Posted : September 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm||Procedure: Computed Tomography Radiation: Fluorine F 18 Clofarabine Procedure: Positron Emission Tomography||Not Applicable|
I. To determine whether positron emission tomography (PET) using the new imaging agent 18F-clofarabine can be used for imaging cancer, and whether interventions that activate the immune system can change the biodistribution of 18F-clofarabine.
Patients receive 18F-clofarabine intravenously (IV) and undergo PET/CT scan at baseline and 2-4 weeks after completion of immunotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Biodistribution of [18F]-Clofarabine in Cancer Patients Before and After Interventions That Increase the Activity of Deoxycytidine Kinase|
|Actual Study Start Date :||June 12, 2015|
|Estimated Primary Completion Date :||June 12, 2020|
|Estimated Study Completion Date :||June 12, 2021|
Experimental: Basic science (18F-clofarabine biodistribution)
Patients receive 18F-clofarabine IV and undergo PET/CT scan at baseline and 2-4 weeks after completion of immunotherapy.
Procedure: Computed Tomography
Undergo 18F-clofarabine PET/CT
Radiation: Fluorine F 18 Clofarabine
Procedure: Positron Emission Tomography
Undergo 18F-clofarabine PET/CT
- 18F-clofarabine concentration in cancer tissue [ Time Frame: Up to 4 weeks ]
- Change in 18F-clofarabine biodistribution [ Time Frame: Baseline to up to 4 weeks ]For the biodistribution studies, regions of interest will be drawn on images of liver, kidney, bladder, heart, lung and blood pool to obtain regional activity count rates. Standardized uptake values (SUV = count activity per ml within region of interest (MBq-1)/(injected dose [MBq]/body weight [kgx1000]) will be calculated for different organs and for regions of tumor. Further, regional target to background count activity ratios will be established.
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): NCT02888301
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Martin Allen-Auerbach 310-983-1444|
|Principal Investigator: Martin Allen-Auerbach|
|Principal Investigator:||Martin Allen-Auerbach||UCLA / Jonsson Comprehensive Cancer Center|