Longitudinal 3He Magnetic Resonance Imaging of Healthy Lung

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT02483403
• Date of registration: 24/06/2015
• Prospective Registration: No
• Primary sponsor: Western University, Canada
• Public title: Longitudinal 3He Magnetic Resonance Imaging of Healthy Lung
• Scientific title: Longitudinal 3He Magnetic Resonance Imaging of Healthy Lung
• Date of first enrolment: September 2010
• Target sample size: 180
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02483403
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Grace E Parraga, PhD
• Affiliation: Robarts Research Institute, The University of Western Ontario

• Name: Grace E Parraga, PhD

• Name: Grace E Parraga, PhD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects male and female aged 60-90

- Subject has a smoking history of < 0.5 pack years

- Subject understands the study procedures and is willing to participate in the study as
indicated by signature on the informed consent

- Subject must be able to perform a breathhold for 16s.

- BMI 18-30

- Subject is judged to be in stable health on the basis of medical history

- Subject able to perform reproducible pulmonary function testing (i.e., the 3 best
acceptable spirograms have FEV1 values that do not vary more than 5% of the largest
value or more than 100 ml, whichever is greater.)

Exclusion Criteria:

- Subject is, in the opinion of the investigator, mentally or legally incapacitated,
preventing informed consent from being obtained, or cannot read or understand the
written material.

- Subject has a history of cardiovascular disorders including coronary insufficiency,
cardiac arrhythmias, severe hypertension (=160 over =100)

- Subject has a daytime room air oxygen saturation <90% while lying supine.

- Subject is unable to perform spirometry or plethysmography maneuvers

- Subject is unable or unwilling to ride a stationary bicycle

- Subject is pregnant

- In the investigator's opinion, subject suffers from any physical, psychological or
other condition(s) that might prevent performance of the MRI, such as severe
claustrophobia.

- Subject has an implanted mechanically, electrically or magnetically activated device
or any metal in their body which cannot be removed, including but not limited to
pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips,
bioprosthesis, artificial limb,



Age minimum: 60 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Other: Hyperpolarized Helium-3

Device: MRI

Primary Outcome(s)

Ventilation Defect Percent (VDP) [Time Frame: 3 years]

Secondary Outcome(s)

Apparent Diffusion Coefficients (ADC) [Time Frame: 3 years]

Secondary ID(s)

ROB0003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors