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

NCT ID: NCT02925351

Last Updated: 2020-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-25

Study Completion Date

2018-04-30

Brief Summary

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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

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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.

Conditions

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Autoimmune Disease Crohn Disease Inflammatory Disorder Rheumatoid Arthritis Systemic Lupus Erythematosus Takayasu Arteritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

pilot
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo PET/CT scan

Fluorine F 18 Clofarabine

Intervention Type RADIATION

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT scan

Interventions

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Computed Tomography

Undergo PET/CT scan

Intervention Type PROCEDURE

Fluorine F 18 Clofarabine

Given IV

Intervention Type RADIATION

Positron Emission Tomography

Undergo PET/CT scan

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT Scan Computerized Axial Tomography Computerized Tomography CT CT SCAN tomography 18F-CA 18F-Clofarabine [18F]-Clofarabine Cl-18F-ara-A Medical Imaging, Positron Emission Tomography PET PET SCAN Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Allen-Auerbach

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

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UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2016-01303

Identifier Type: REGISTRY

Identifier Source: secondary_id

15-001600

Identifier Type: OTHER

Identifier Source: secondary_id

15-001600

Identifier Type: -

Identifier Source: org_study_id

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