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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02888301
• Other study ID #: 15-000246
• Secondary ID: NCI-2016-0021015
• Status: Terminated
• Start date: June 12, 2015
• Est. completion date: April 30, 2018

Study information

• Verified date: February 2019
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Procedure:
• Computed Tomography
Undergo 18F-clofarabine PET/CT

Radiation:
• Fluorine F 18 Clofarabine
Given IV

Procedure:
• Positron Emission Tomography
Undergo 18F-clofarabine PET/CT

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	18F-clofarabine concentration in cancer tissue		Up to 4 weeks
Primary	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