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

This study is currently recruiting participants.
Verified October 2017 by Jonsson Comprehensive Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02925351
First Posted: October 5, 2016
Last Update Posted: October 13, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
  Purpose
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.

Condition Intervention
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory Diseases

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Actual Study Start Date: January 25, 2016
Estimated Study Completion Date: January 25, 2022
Estimated Primary Completion Date: January 25, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography
Radiation: Fluorine F 18 Clofarabine
Given IV
Other Names:
  • 18F-CA
  • 18F-Clofarabine
  • [18F]-Clofarabine
  • Cl-18F-ara-A
Procedure: Positron Emission Tomography
Undergo PET/CT scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
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         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Martin Allen-Auerbach UCLA / Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02925351     History of Changes
Other Study ID Numbers: 15-001600
NCI-2016-01303 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
15-001600 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
P30CA016042 ( U.S. NIH Grant/Contract )
First Submitted: September 8, 2016
First Posted: October 5, 2016
Last Update Posted: October 13, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Vasculitis
Arthritis, Rheumatoid
Crohn Disease
Lupus Erythematosus, Systemic
Autoimmune Diseases
Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Immune System Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Skin Diseases, Vascular
Skin Diseases
Clofarabine
Fluorides
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents