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

Study Overview
=================
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.

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

Conditions
-----------------
Malignant Neoplasm

Intervention / Treatment
-----------------
* Procedure: Computed Tomography
* Radiation: Fluorine F 18 Clofarabine
* Procedure: Positron Emission Tomography


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Basic science (18F-clofarabine biodistribution)<br>Patients receive 18F-clofarabine IV and undergo PET/CT scan at baseline and 2-4 weeks after completion of immunotherapy. | Procedure: Computed Tomography<br>* Undergo 18F-clofarabine PET/CT<br>* Other names: tomography;Radiation: Fluorine F 18 Clofarabine<br>* Given IV<br>* Other names: Cl-18F-ara-A;Procedure: Positron Emission Tomography<br>* Undergo 18F-clofarabine PET/CT<br>* Other names: proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |