NCT03431129

Terminated

Hyperpolarized 129Xe Magnetic Resonance Imaging for Evaluati...

The Hospital for Sick Children Source

The Hospital for Sick Children

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

1000056200

Study Type

observational

Actual enrollment (reported)

1

Locations

1 country

Sites

1

Timeline

Study Start

September 1, 2018

Actual (reported)

Primary Completion

November 1, 2019

Actual (reported)

Study Completion

November 1, 2019

Actual (reported)

Brief Summary

The purpose of this work is to perform hyperpolarized (HP) 129Xe MRI in human subjects undergoing thoracic radiation therapy (RT), both before, during and following RT. HP 129Xe MR images will be analysed to provide maps of ventilation (V), perfusion (Q), apparent diffusion coefficient (ADC) and gas exchange. These results will be combined to yield a new measure of RILI, (i.e. dose volume histograms; DVHV/Q) and compared with conventional dose volume histograms (DVH), pulmonary function tests (PFTs), quality of life (QOL) questionnaire and CT measurements for assessment of RILI at each time point. The aim is to development a novel method for early and more sensitive method of detecting RILI before irreversible lung damage happens.

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): 1 participants
Study completion date: November 1, 2019
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

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

First Submitted
February 7, 2018
Actual (reported)
First Posted
February 13, 2018
Actual (reported)
Study Start
September 1, 2018
Actual (reported)
Primary Completion
November 1, 2019
Actual (reported)
Study Completion
November 1, 2019
Actual (reported)

Last Updated: August 1, 2025
Status Verified: July 2025
Last Update Submitted: July 29, 2025

Conditions

Radiation Induced Lung Injury (RILI)

Keywords

Xenon MRI, Lung, Radiation Induced Lung Injury,

Outcome Measures

Primary Outcomes (1)

DVHV/Q
In-house software will be used to generate the ventilation, perfusion and gas exchange maps and calculate DVHV/Q
2 years

Interventions

Hyperpolarized gas and proton lung MRIDiagnostic test

Lung MRI for participants undergoing radiation therapy (RT)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Sampling MethodProbability Sample

Study Population

Participant will be recruited from Princess Margaret Hospital, Toronto, Ontario and Juravinski Cancer Centre, Hamilton, Ontario.

Contact the study team to confirm eligibility.

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

1 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Senior Scientist

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 13, 2018

Study Start

September 1, 2018

Actual (reported)

Primary Completion

November 1, 2019

Actual (reported)

Study Completion

November 1, 2019

Actual (reported)

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
Time Frame: The data will be available after enrolling the first participant and will be available for the duration of the study

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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

Registry identifier: NCT03431129
Data provider: ClinicalTrials.gov
Source updated: 2025-08-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:31 UTC

Locations

CA(1)

Study Stopped

Hyperpolarized 129Xe Magnetic Resonance Imaging for Evaluation of Radiation-Induced Lung Injury in Subjects Undergoing Thoracic Irradiation

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations