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

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Brief Title

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

Official Title

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

Brief Summary

      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

      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.

Study Phase

Early Phase 1

Study Type

Interventional

Primary Outcome

Standardized Uptake Value

Condition

Autoimmune Disease

Intervention

Computed Tomography

Study Arms / Comparison Groups

 Imaging (fluorine F 18 clofarabine, PET/CT)
Description:  Patients receive fluorine F 18 clofarabine IV and undergo a single PET/CT scan for up to 120 minutes.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

8

Start Date

January 25, 2016

Completion Date

April 30, 2018

Primary Completion Date

April 30, 2018

Eligibility Criteria

        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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Martin Allen-Auerbach, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02925351

Organization ID

15-001600

Secondary IDs

NCI-2016-01303

Responsible Party

Sponsor

Study Sponsor

Jonsson Comprehensive Cancer Center

Study Sponsor

Martin Allen-Auerbach, Principal Investigator, UCLA / Jonsson Comprehensive Cancer Center

Verification Date

November 2019