Functional Applications of Hyperpolarized 129Xe MRI

NCT01697332 | Terminated Phase 1 Results DMC FDA Drug

• 2 other identifiers: 2012P0019475R01HL096471-04
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objectives of our study are to determine the capabilities of hyperpolarized 129Xe MRI to measure lung function and its potential to sensitively detect pulmonary disease and its progression in COPD. We hypothesize that measurement of alveolar surface area, septal thickness, and capillary transit time measured with hyperpolarized 129Xe will correlate better with quality of life measures in COPD subjects than traditional diagnostic measures such as spirometry and Computed Tomography.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (3)

• Baseline Statistics of Healthy Subjects

  Hyperpolarized 129Xe MRI scans will be performed on healthy subjects and the uptake of 129Xe in the pulmonary septal tissue will be measured as a function of time. From this data, the mean and distribution of three pulmonary functional parameters will be determined. The three measures are alveolar surface area per unit volume, septal thickness and capillary transit time through the gas exchange region.

  4 years

• Differences Between Healthy and Diseased COPD Subjects.

  Hyperpolarized 129Xe MRI measures of disease severity in GOLD Stage 1-3 subjects are more highly correlated with physical disabilities associated with their pulmonary disease than traditional tests of pulmonary function.

  4 years

• Spatial Heterogeneity

  Determine the degree to which the spatial heterogeneity of regional 129Xe measurements of pulmonary function in a single individual correlates with physical manifestations of disease severity. We hypothesize that measures of spatial heterogeneity will correlate highly with physical disability.

  4 years

Study Arms (1)

Subjects with and without COPD

EXPERIMENTAL

All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.

Drug: Hyperpolarized 129Xe gas

Interventions

Hyperpolarized 129Xe gas DRUG

800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon.

Subjects with and without COPD

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-75
• For Healthy nonsmoker subjects:
• No current physician diagnosed medical disease requiring active medication
• No smoking history, defined as less than 100 cigarettes smoked in a lifetime
• Normal spirometry: FEV1/FVC ≥ 0.70, FEV1 ≥ 80% predicted
• For Subjects who have participated in the COPDGene Study
• Post-bronchodilator spirometry: FEV1 \> 40% predicted

You may not qualify if:

• MR contraindications: e.g., electrical implants such as cardiac pacemakers, ferromagnetic implants such as prostheses, claustrophobia
• Pregnancy or suspected pregnancy
• Use of continuous oxygen
• Use of antibiotics and/or systemic corticosteroids (new prescription or increased dose) for an exacerbation of lung disease or any lung infection in the past four weeks
• Uncontrolled cancer, as defined as ongoing radiation therapy, ongoing chemotherapy
• A heart attack in the past three months

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Samuel Patz
• Organization: Brigham and Women's Hospital

patz@bwh.harvard.edu

6172780616

Study Officials

• Samuel Patz, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director, Center for Pulmonary Functional Imaging

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: October 2, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 17, 2018
• Results First Posted: April 17, 2018

Record last verified: 2018-03

Locations

US (1)