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

Primary Purpose

Autoimmune Disease, Crohn Disease, Inflammatory Disorder

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Fluorine F 18 Clofarabine
Positron Emission Tomography
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Autoimmune Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA / Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imaging (fluorine F 18 clofarabine, PET/CT)

Arm Description

Patients receive fluorine F 18 clofarabine IV and undergo a single PET/CT scan for up to 120 minutes.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 8, 2016
Last Updated
September 2, 2020
Sponsor
Jonsson Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02925351
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 25, 2016 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Disease, Crohn Disease, Inflammatory Disorder, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Takayasu Arteritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
pilot
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imaging (fluorine F 18 clofarabine, PET/CT)
Arm Type
Experimental
Arm Description
Patients receive fluorine F 18 clofarabine IV and undergo a single PET/CT scan for up to 120 minutes.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography
Intervention Description
Undergo PET/CT scan
Intervention Type
Radiation
Intervention Name(s)
Fluorine F 18 Clofarabine
Other Intervention Name(s)
18F-CA, 18F-Clofarabine, [18F]-Clofarabine, Cl-18F-ara-A
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo PET/CT scan
Primary Outcome Measure Information:
Title
Standardized Uptake Value
Description
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.
Time Frame
Baseline up to 240 minutes after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Allen-Auerbach
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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

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