NCT02195206

Terminated

Hyperpolarized Xenon-129 Lung and/or Brain Magnetic Resonanc...

The Hospital for Sick Children Source

The Hospital for Sick Children

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

1000041669

Study Type

observational

Actual enrollment (reported)

40

Locations

1 country

Sites

1

Timeline

Study Start

July 2014

Actual (reported)

Primary Completion

June 27, 2024

Actual (reported)

Study Completion

June 27, 2024

Actual (reported)

Brief Summary

In this pilot study, MRI of the lungs and/or brain of healthy adult volunteers will be performed at 3Tesla to assess image quality using a prototype chest coil and pulse sequence following inhalation of hyperpolarized 129Xe (xenon) gas. This study will take place at the Hospital for Sick Children, Toronto, Canada. Ninety subjects aged 18 to 75 will participate in this study. Xenon MRI is a non-invasive imaging technique that does not involve X-rays or ionizing radiation. Rather, this imaging method utilizes the same hardware and software principles that are used for conventional proton MRI of patients in a hospital. The investigators are testing the abilities of xenon MRI to see if it will produce lung and/or brain images of equal or better quality to that of proton MRI. The investigators hypothesize that they will get good quality images of the lungs and/or brain for analysis using our method.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 40 participants
Study completion date: June 27, 2024
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 19, 2014
Actual (reported)
Study Start
July 2014
Actual (reported)
First Posted
July 21, 2014
Actual (reported)
Primary Completion
June 27, 2024
Actual (reported)
Study Completion
June 27, 2024
Actual (reported)

Last Updated: September 4, 2025
Status Verified: August 2025
Last Update Submitted: August 27, 2025

Conditions

Healthy

Keywords

Hyperpolarized gas magnetic resonance imagingHyperpolarized Xenon-129 magnetic resonance imagingLung and/or brain ImagingHealthy Adults

Outcome Measures

Primary Outcomes (1)

Ventilation Defect Volume
Volume of the lung not being ventilated to the optimum level
Day 1

Secondary Outcomes (2)

Apparent Diffusion Coefficient
Day 1
129 Xe Brain MRI feasibility
Day 1

Other Outcomes (1)

Signal to Noise Ratio
Day 1

Study Arms (1)

Healthy

Adult

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Healthy Adults from the general population

You may qualify if:

Subjects male and female aged 18-75

Sponsors & Collaborators

The Hospital for Sick Children
Otherlead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Study Officials

Giles Santyr, PhD
The Hospital for Sick Children
PRINCIPAL INVESTIGATOR

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: CROSS SECTIONAL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: PhD, FCCPM, Senior Scientist, The Hospital for Sick Children

Study Record Dates

First Submitted

June 19, 2014

First Posted

July 21, 2014

Study Start

July 2014

Actual (reported)

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Subject has a smoking history of ≤ 1 pack year

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 breath hold for 16 seconds

Subject has a Body Mass Index (BMI) between 18 and 40

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

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

You may not qualify if:

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 chronic or acute respiratory disease
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 ≤ 92% ± 2% while supine
Subject is unable to perform spirometry or plethysmography maneuvers
Subject is pregnant or lactating
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 MRI incompatible 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, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants)

Contact the study team to confirm eligibility.

Primary Completion

June 27, 2024

Actual (reported)

Study Completion

June 27, 2024

Actual (reported)

Last Updated

September 4, 2025

Record last verified: 2025-08

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02195206
Data provider: ClinicalTrials.gov
Source updated: 2025-09-04
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:50 UTC

Locations

CA(1)

Study Stopped

Hyperpolarized Xenon-129 Lung and/or Brain Magnetic Resonance Imaging: Healthy Adult Volunteer Pilot Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (1)

Study Arms (1)

Healthy

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (1)

Study Arms (1)

Healthy

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations