Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders

NCT00846573 | Terminated Results

• 1 other identifier: Docket # 12639
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the efficacy of Hyperpolarized Helium-3 gas in MR imaging in COPD, asthmatics, CF and healthy volunteers.

Conditions

COPD; Cystic Fibrosis; Asthma; Healthy

Keywords

Helium; MRI; Hyperpolarized Helium; Hyperpolarized Noble Gas

Outcome Measures

Primary Outcomes (1)

• Hyperpolarized Helium-3 MR Images

  We have applied hyperpolarized 3He MR imaging to a range of subject with various disorders. We have developed our scanning techniques so as to acquire optimized images for each disorder.

  15 second breath-hold

Study Arms (4)

Asthmatic Participants

EXPERIMENTAL

This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.

Drug: Hyperpolarized Helium-3

Healthy

EXPERIMENTAL

This population is made up of subjects who are considered clinically healthy. This means that there are no records of any chronic disorders or pulmonary history. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.

Drug: Hyperpolarized Helium-3

COPD Patients

EXPERIMENTAL

This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.

Drug: Hyperpolarized Helium-3

Cystic Fibrosis Patients

EXPERIMENTAL

This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.

Drug: Hyperpolarized Helium-3

Interventions

Hyperpolarized Helium-3 DRUG

Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.

Also known as: HP 3He

Asthmatic Participants; COPD Patients; Cystic Fibrosis Patients; Healthy

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Are male or female and are 5 years or older
• Consent/assent from the patient
• Have been diagnosed with a pulmonary disease such as COPD, Asthma, or cystic fibrosis. OR Healthy Individuals.
• Must be able to hold their breath for up to 15 seconds

You may not qualify if:

• Have any contraindications to an MR exam such as a pace-maker, metallic cardiac valves, magnetic material (i.e., surgical clips) implanted electronic infusion pumps or any other conditions that would preclude proximity to a strong magnetic field;
• Are undergoing the MR exam in an emergency situation
• Are pregnant or become pregnant at any point within the study time.
• People with psychiatric disorders will be excluded from the study.
• Are claustrophobic and can not tolerate the imaging.
• Uses supplemental oxygen

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMASS Medical School Advanced MRI Center United States

Worcester, Massachusetts, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cystic Fibrosis; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Mitchell Albert
• Organization: UMass Medical School

albertmi@tbh.net

(617) 875-2141

Study Officials

• Mitchell S Albert, Ph.D.

  UMASS Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Advanced MRI Center, UMASS Medical Sch

Study Record Dates

• First Submitted: February 16, 2009
• First Posted: February 18, 2009
• Study Start: November 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 15, 2012
• Results First Posted: November 9, 2012

Record last verified: 2012-11

Locations

US (1)