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Completed

NCT Number: NCT02925351

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

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.

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Key information

Conditions

Autoimmune Disease Aortic Arch Syndromes Aortic Diseases Arteritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Cardiovascular Diseases Connective Tissue Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Immune System Diseases Inflammatory Bowel Diseases Inflammatory Disorder Intestinal Diseases Joint Diseases Lupus Erythematosus, Systemic Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Lupus Erythematosus Takayasu Arteritis Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Computed Tomography

Procedure

Undergo PET/CT scan

Other names: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography

Fluorine F 18 Clofarabine

Radiation

Given IV

Other names: 18F-CA, 18F-Clofarabine, [18F]-Clofarabine, Cl-18F-ara-A

Positron Emission Tomography

Procedure

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2016
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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