Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory Diseases

Study Overview
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Brief Summary
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This pilot trial studies how well fluorine F 18 clofarabine positron emission tomography (PET)/computed tomography (CT) works in imaging patients with autoimmune or inflammatory diseases. Fluorine F 18 clofarabine is an imaging agent or tracer which may be taken up by inflammatory tissue in the body. Diagnostic imaging, such as PET/CT scans, can be used to measure the amount of injected tracer that is taken up by inflammatory tissue. PET/CT scan may help to determine how fluorine F 18 clofarabine is distributed throughout the body.

Detailed Description
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PRIMARY OBJECTIVES: 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. OUTLINE: Patients receive fluorine F 18 clofarabine intravenously (IV) and undergo a single PET/CT scan for up to 120 minutes.

Official Title
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The Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory Diseases

Conditions
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Autoimmune Disease, Crohn Disease, Inflammatory Disorder, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Takayasu Arteritis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be 18 years or older. Diagnosed with an autoimmune and inflammatory disorder. Exclusion Criteria Women of childbearing age will have to undergo a pregnancy test that will be provided free of charge. Patients unable to undergo or comply with PET/CT scanning due to pre-existing medical conditions including claustrophobia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: pilot
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imaging (fluorine F 18 clofarabine, PET/CT)<br>Patients receive fluorine F 18 clofarabine IV and undergo a single PET/CT scan for up to 120 minutes. | Procedure: Computed Tomography<br>* Undergo PET/CT scan<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 PET/CT scan<br>* Other names: proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized Uptake Value | 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. | Baseline up to 240 minutes after injection |