Trial Outcomes & Findings for MRI for Non-Invasive Imaging in Neonates and Children (NCT NCT02163681)

NCT ID: NCT02163681

Last Updated: 2022-04-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2022-04-19

Participant Flow

Participant milestones

Measure	Hyperpolarized Helium 3 MRI of the Chest Using hyperpolarized helium-3 as an inhaled contrast agent for MRI, we will assess the lung ventilation. Hyperpolarized Helium-3 MRI of the chest: hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation.
Overall Study STARTED	45
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MRI for Non-Invasive Imaging in Neonates and Children

Baseline characteristics by cohort

Measure	Hyperpolarized Helium 3 MRI of the Chest n=44 Participants Using hyperpolarized helium-3 as an inhaled contrast agent for MRI, we will assess the lung ventilation. Hyperpolarized Helium-3 MRI of the chest: hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation.
Age, Continuous	5.5 years STANDARD_DEVIATION 5.0 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: 6 of the 44 imaged subjects were part of the technique development and were not included in the data analysis.

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.

Outcome measures

Measure	Hyperpolarized Helium 3 MRI of the Chest n=38 Participants Using hyperpolarized helium-3 as an inhaled contrast agent for MRI, we will assess the lung ventilation. Hyperpolarized Helium-3 MRI of the chest: hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation.
Ventilation Defects as Seen on Hyperpolarized Helium-3 MRI No Defects	9 Participants
Ventilation Defects as Seen on Hyperpolarized Helium-3 MRI Small Defects	13 Participants
Ventilation Defects as Seen on Hyperpolarized Helium-3 MRI Large Defects	16 Participants

Adverse Events

Hyperpolarized Helium 3 MRI of the Chest

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Hyperpolarized Helium 3 MRI of the Chest n=44 participants at risk Using hyperpolarized helium-3 as an inhaled contrast agent for MRI, we will assess the lung ventilation. Hyperpolarized Helium-3 MRI of the chest: hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation.
General disorders Headache/sore throat	2.3% 1/44 • Number of events 1 • 1 week Patients or their family were contacted within 1 to 5 days after completion of imaging.
General disorders Fever	2.3% 1/44 • Number of events 1 • 1 week Patients or their family were contacted within 1 to 5 days after completion of imaging.
Gastrointestinal disorders Upset Stomach/vomiting/gas	6.8% 3/44 • Number of events 3 • 1 week Patients or their family were contacted within 1 to 5 days after completion of imaging.

Additional Information

Talissa Altes, MD

University of Missouri

Phone: 573-882-1026

Email: altest@health.missouri.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place