MRI for Non-Invasive Imaging in Neonates and Children

NCT02163681 | Completed Results

• 1 other identifier: 15720
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop rapid MRI techniques for imaging the lung with hyperpolarized helium-3 gas as an inhaled contrast agent. These techniques will be piloted in adults and older children before testing them in younger children and infants. The purpose is to enable imaging of non-sedated infants by imaging so fast as to freeze motion.

Conditions

Healthy; Cystic Fibrosis (CF); Asthma; Bronchopulmonary Dysplasia (BPD)

Outcome Measures

Primary Outcomes (1)

• Ventilation Defects as Seen on Hyperpolarized Helium-3 MRI

  On hyperpolarized helium-3 MRI, well ventilated areas of the lung appear bright and poorly ventilated areas appear dark. The poorly ventilated areas are called ventilation defects. Human readers looked at the hyperpolarized helium-3 MR images and determined whether the lungs had: No Defects, Small Defects, or Large Defects.

  Day 1

Study Arms (1)

Hyperpolarized Helium 3 MRI of the chest

EXPERIMENTAL

Using hyperpolarized helium-3 as an inhaled contrast agent for MRI, we will assess the lung ventilation.

Drug: Hyperpolarized Helium-3 MRI of the chest

Interventions

Hyperpolarized Helium-3 MRI of the chest DRUG

hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation.

Hyperpolarized Helium 3 MRI of the chest

Eligibility Criteria

• Age: 4 Months - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• MRI sequence development (n=40): Healthy subjects and patients with CF, BPD, or asthma will be used in the development of the rapid imaging techniques. These subjects will be age 4 months to 65 years old. Healthy subjects can have no history of chronic respiratory disease. The subjects with CF or asthma must have a physician diagnosis of their respective disease.
• Proof-of-Concept Study (n=30): Ten healthy infants,10 infants with CF, and 10 infants with BPD age 4-24 months will be imaged in the proof-of-concept study. Healthy infant must have had an uncomplicated term birth and have no history of chronic respiratory symptoms. The patients with CF must have a physician diagnosis of CF and be at their baseline clinical status on the day of imaging.

You may not qualify if:

• Any condition for which a MRI procedure is contraindicated.
• Presence of any non-MRI compatible metallic material in the body, such as pacemakers, metallic clips, etc.
• Likelihood of claustrophobia
• Chest circumference greater than that of the helium magnetic resonance (MR) coil.
• Pregnancy, by report of subject. Clinically in the Department of Radiology at UVA, self report is used when screening patients for MR scans as well as CT scans and fluoroscopy studies. If the subject reports there is any chance of their being pregnant a urine pregnancy test will be performed prior to any imaging.

Sponsors & Collaborators

• University of Virginia: lead
• Xemed LLC: collaborator

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Asthma; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases

Results Point of Contact

• Title: Talissa Altes, MD
• Organization: University of Missouri

altest@health.missouri.edu

573-882-1026

Study Officials

• Yun M Shim, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 16, 2014
• Study Start: January 1, 2011
• Primary Completion: June 30, 2018
• Study Completion: July 30, 2018
• Last Updated: April 19, 2022
• Results First Posted: April 19, 2022

Record last verified: 2022-03

Locations

US (1)