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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Procedure: Computed Tomography Radiation: Fluorine F 18 Clofarabine Procedure: Positron Emission Tomography Not Applicable

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 : 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

Resource links provided by the National Library of Medicine

Drug Information available for: Clofarabine

Arm Intervention/treatment
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
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography

Radiation: Fluorine F 18 Clofarabine
Given IV
Other Names:
  • 18F-CA
  • 18F-Clofarabine
  • [18F]-Clofarabine
  • Cl-18F-ara-A

Procedure: Positron Emission Tomography
Undergo 18F-clofarabine PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. 18F-clofarabine concentration in cancer tissue [ Time Frame: Up to 4 weeks ]
  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Martin Allen-Auerbach UCLA / Jonsson Comprehensive Cancer Center

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02888301     History of Changes
Other Study ID Numbers: 15-000246
NCI-2016-00210 ( Registry Identifier: CTRP )
15-000246 2 scan clofarabine
15-000246 ( Other Identifier: JCCC )
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Neoplasms
Clofarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents