Malignant Neoplasm
Conditions
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.
Interventions
PROCEDUREComputed Tomography
Undergo 18F-clofarabine PET/CT
RADIATIONFluorine F 18 Clofarabine
Given IV
PROCEDUREPositron Emission Tomography
Undergo 18F-clofarabine PET/CT
Sponsors
Jonsson Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed