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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02925351
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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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.

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 Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: pilot
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory Diseases
Actual Study Start Date : January 25, 2016
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, California
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Martin Allen-Auerbach UCLA / Jonsson Comprehensive Cancer Center
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02925351    
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 )
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Skin Diseases, Vascular
Skin Diseases
Clofarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents