NCT03431129

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

February 7, 2018

Last Update Submit

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)

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

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Study Officials

  • Giles Santyr, PhD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

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

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Data will be shared between the three participating sites in the study. A data transfer agreement has been implemented to enable this transfer smoothly.

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

Locations

CA(1)