Trial Outcomes & Findings for Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders (NCT NCT00846573)

Last Updated: 2012-11-15

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

15 second breath-hold

Results posted on

2012-11-15

Participant Flow

Recruitment began November 2008 and enrollment started January 2009. Recruitment continued until the study was terminated, April 2011. Participants were asthmatics, COPD patients, or CF patients as confirmed by their physician. Recruitment was completed from the UMass Memorial Medical Centre. Alternatively, healthy volunteers were also recruited.

Participants were excluded if their diagnosis of a lung condition could not be confirmed by medical records.

Participant milestones

Participant milestones
Measure	COPD 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.	Asthma 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.	Cystic Fibrosis 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.
Overall Study STARTED	5	2	7
Overall Study COMPLETED	5	2	7
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	COPD Patients n=5 Participants 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.	Asthma Patients n=2 Participants 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.	Cystic Fibrosis Patients n=7 Participants 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.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	13 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	24.4 years STANDARD_DEVIATION 9.74 • n=5 Participants	34.5 years STANDARD_DEVIATION 14.85 • n=7 Participants	27 years STANDARD_DEVIATION 8.25 • n=5 Participants	27.14 years STANDARD_DEVIATION 9.42 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants	14 participants n=4 Participants

PRIMARY outcome

Timeframe: 15 second breath-hold

Population: We recruited participants of each category until we were satisfied with the images we obtained.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=5 Participants 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.	Asthma Patients n=2 Participants 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.	Cystic Fibrosis Patients n=7 Participants 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.
Hyperpolarized Helium-3 MR Images	5 participants	2 participants	7 participants

Adverse Events

COPD Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Asthma Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cystic Fibrosis Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mitchell Albert

UMass Medical School

Phone: (617) 875-2141

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60