Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory Diseases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02925351|
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Autoimmune Disease Crohn Disease Inflammatory Disorder Rheumatoid Arthritis Systemic Lupus Erythematosus Takayasu Arteritis||Procedure: Computed Tomography Radiation: Fluorine F 18 Clofarabine Procedure: Positron Emission Tomography||Not Applicable|
I. Determine how fluorine F 18 clofarabine (18F‐clofarabine) is distributed in the body, in patients with autoimmune and inflammatory diseases.
II. Determine whether 18F‐clofarabine can be used to image patients with autoimmune and inflammatory diseases.
Patients receive fluorine F 18 clofarabine intravenously (IV) and undergo a single PET/CT scan for up to 120 minutes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory Diseases|
|Actual Study Start Date :||January 25, 2016|
|Estimated Primary Completion Date :||January 25, 2021|
|Estimated Study Completion Date :||January 25, 2022|
U.S. FDA Resources
Experimental: Imaging (fluorine F 18 clofarabine, PET/CT)
Patients receive fluorine F 18 clofarabine IV and undergo a single PET/CT scan for up to 120 minutes.
Procedure: Computed Tomography
Undergo PET/CT scan
Other Names:Radiation: Fluorine F 18 Clofarabine
Other Names:Procedure: Positron Emission Tomography
Undergo PET/CT scan
- Standardized Uptake Value [ Time Frame: Baseline up to 240 minutes after injection ]Standardized Uptake Value (SUV) will be the primary unit for assessment. Using standard PET/CT viewing software, the SUV will be measured for different organs and lesions of suspected disease and compared to reference/background tissues.
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): NCT02925351
|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|
|Principal Investigator:||Martin Allen-Auerbach||UCLA / Jonsson Comprehensive Cancer Center|