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

Rheumatoid Arthritis Clinical Trial

Official title:

The Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925351
• Other study ID #: 15-001600
• Secondary ID: NCI-2016-0130315
• Status: Completed
• Phase: Early Phase 1
• Start date: January 25, 2016
• Est. completion date: April 30, 2018

Study information

• Verified date: November 2019
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Computed Tomography
Undergo PET/CT scan

Radiation:
• Fluorine F 18 Clofarabine
Given IV

Procedure:
• Positron Emission Tomography
Undergo PET/CT scan

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to 240 minutes after injection