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

NCT02925351 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: 15-001600NCI-2016-01303
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Imaging (fluorine F 18 clofarabine, PET/CT)

EXPERIMENTAL

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

Procedure: Computed Tomography; Radiation: Fluorine F 18 Clofarabine; Procedure: Positron Emission Tomography

Interventions

Computed Tomography PROCEDURE

Undergo PET/CT scan

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography

Imaging (fluorine F 18 clofarabine, PET/CT)

Fluorine F 18 Clofarabine RADIATION

Given IV

Also known as: 18F-CA, 18F-Clofarabine, [18F]-Clofarabine, Cl-18F-ara-A

Imaging (fluorine F 18 clofarabine, PET/CT)

Positron Emission Tomography PROCEDURE

Undergo PET/CT scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Imaging (fluorine F 18 clofarabine, PET/CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 18 years or older.
• Diagnosed with an autoimmune and inflammatory disorder.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Autoimmune Diseases; Crohn Disease; Arthritis, Rheumatoid; Lupus Erythematosus, Systemic; Takayasu Arteritis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Immune System Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Martin Allen-Auerbach

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pilot

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: October 5, 2016
• Study Start: January 25, 2016
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: September 4, 2020

Record last verified: 2019-11

Locations

US (1)