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

Terminated

• Conditions: Malignant Neoplasm
• Interventions: Procedure: Computed Tomography; Radiation: Fluorine F 18 Clofarabine; Procedure: Positron Emission Tomography

• Registration Number: NCT02888301
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-06-12
• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-09-05
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2019-02
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Basic science (18F-clofarabine biodistribution)	Computed Tomography	Patients receive 18F-clofarabine IV and undergo PET/CT scan at baseline and 2-4 weeks after completion of immunotherapy.
Basic science (18F-clofarabine biodistribution)	Fluorine F 18 Clofarabine	Patients receive 18F-clofarabine IV and undergo PET/CT scan at baseline and 2-4 weeks after completion of immunotherapy.
Basic science (18F-clofarabine biodistribution)	Positron Emission Tomography	Patients receive 18F-clofarabine IV and undergo PET/CT scan at baseline and 2-4 weeks after completion of immunotherapy.

Primary Outcome Measures

Name	Time	Method
18F-clofarabine concentration in cancer tissue	Up to 4 weeks
Change in 18F-clofarabine biodistribution	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.

Trial Locations

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States