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

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT02925351
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
27.1
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Computed Tomography
  • Radiation: Fluorine F 18 Clofarabine
  • Procedure: Positron Emission Tomography
 Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:

  1. Determine how fluorine F 18 clofarabine (18F-clofarabine) is distributed in the body, in patients with autoimmune and inflammatory diseases.

  2. 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

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
pilotpilot
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 :
Jan 25, 2016
Actual Primary Completion Date :
Apr 30, 2018
Actual Study Completion Date :
Apr 30, 2018

Arms and Interventions

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

    Primary Outcome Measures

    1. Standardized Uptake Value [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 UCLA / Jonsson Comprehensive Cancer Center Los Angeles California United States 90095

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonsson Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02925351
    Other Study ID Numbers:
    • 15-001600
    • NCI-2016-01303
    • 15-001600
    First Posted:
    Oct 5, 2016
    Last Update Posted:
    Sep 4, 2020
    Last Verified:
    Nov 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Crohn Disease
    Arteritis
    Takayasu Arteritis
    Aortic Arch Syndromes
    Lupus Erythematosus, Systemic
    Autoimmune Diseases
    Clofarabine

    Study Results

    No Results Posted as of Sep 4, 2020