Study Stopped
slow accrual
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
2 other identifiers
observational
12
1 country
1
Brief Summary
This clinical trial studies 18F-clofarabine positron emission tomography (PET)/computed tomography (CT) in imaging patients with cancer before and after treatment with a therapy that activates the patient's immune system (immunotherapy). PET/CT scans give detailed pictures of areas inside the body. 18F-clofarabine is a drug that contains a radioactive substance that is taken up by cells expressing deoxycytidine kinase (dCK), which is highly expressed in activated immune cells, making them light up during PET/CT scans. Doctors also want to know how 18F-clofarabine is distributed throughout the body before and after treatment with immunotherapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 12, 2015
CompletedFirst Submitted
Initial submission to the registry
August 30, 2016
CompletedFirst Posted
Study publicly available on registry
September 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2018
CompletedAugust 12, 2020
February 1, 2019
2.9 years
August 30, 2016
August 10, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
18F-clofarabine concentration in cancer tissue
Up to 4 weeks
Change in 18F-clofarabine biodistribution
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
Study Arms (1)
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.
Interventions
Undergo 18F-clofarabine PET/CT
Given IV
Undergo 18F-clofarabine PET/CT
Eligibility Criteria
Adult cancer patients under treatment using immune system activating interventions.
You may qualify if:
- 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
You may not qualify if:
- Women of childbearing age will have to undergo a pregnancy test that will be provided free of charge
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Allen-Auerbach
UCLA / Jonsson Comprehensive Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2016
First Posted
September 5, 2016
Study Start
June 12, 2015
Primary Completion
April 30, 2018
Study Completion
April 30, 2018
Last Updated
August 12, 2020
Record last verified: 2019-02