- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02888301
18F-Clofarabine PET/CT in Imaging Cancer Patients Before and After Interventions
The Biodistribution of [18F]-Clofarabine in Cancer Patients Before and After Interventions That Increase the Activity of Deoxycytidine Kinase
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
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.
OUTLINE:
Patients receive 18F-clofarabine intravenously (IV) and undergo PET/CT scan at baseline and 2-4 weeks after completion of immunotherapy.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA / Jonsson Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Must be able to tolerate PET/CT (i.e. not claustrophobic and able to remain supine)
- No restrictions based on gender or racial/ethnic background
Exclusion Criteria:
- Women of childbearing age will have to undergo a pregnancy test that will be provided free of charge
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Given IV
Other Names:
Undergo 18F-clofarabine PET/CT
Other Names:
Undergo 18F-clofarabine PET/CT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
18F-clofarabine concentration in cancer tissue
Time Frame: Up to 4 weeks
|
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.
|
Baseline to up to 4 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Martin Allen-Auerbach, UCLA / Jonsson Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-000246 (Other Identifier: JCCC)
- NCI-2016-00210 (Registry Identifier: CTRP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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