18F-Clofarabine PET/CT in Imaging Cancer Patients Before and After Interventions

August 10, 2020 updated by: Jonsson Comprehensive Cancer Center

The Biodistribution of [18F]-Clofarabine in Cancer Patients Before and After Interventions That Increase the Activity of Deoxycytidine Kinase

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.

Study Overview

Status

Terminated

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

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA / Jonsson Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult cancer patients under treatment using immune system activating interventions.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Radiation: Fluorine F 18 Clofarabine
Given IV
Other Names:
  • 18F-CA
  • 18F-Clofarabine
  • [18F]-Clofarabine
  • Cl-18F-ara-A
Procedure: Computed Tomography
Undergo 18F-clofarabine PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • tomography
  • CT SCAN
Procedure: Positron Emission Tomography
Undergo 18F-clofarabine PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PET SCAN

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

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Investigators

  • Principal Investigator: Martin Allen-Auerbach, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2015

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

August 30, 2016

First Submitted That Met QC Criteria

August 30, 2016

First Posted (Estimate)

September 5, 2016

Study Record Updates

Last Update Posted (Actual)

August 12, 2020

Last Update Submitted That Met QC Criteria

August 10, 2020

Last Verified

February 1, 2019

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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