Ignite Creation Date:
2024-05-06 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03431129
Status:
TERMINATED
Last Update Posted:
2023-11-22
First Post:
2018-02-07
Brief Title:
Hyperpolarized 129Xe Magnetic Resonance Imaging for Evaluation of Radiation-Induced Lung Injury in Subjects Undergoing Thoracic Irradiation
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Hyperpolarized 129Xe Magnetic Resonance Imaging for Evaluation of Radiation-Induced Lung Injury in Subjects Undergoing Thoracic Irradiation
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient recruitment and not enough funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RILI
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 ie dose volume histograms DVHVQ 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
Detailed Description:
Briefly at the beginning of an approximate three hour study visit the qualified investigator QI delegate will explain the study procedure to the participants and the participants will have an opportunity to ask questions regarding the study procedure Following the explanation of the study written informed consent will be collected During the study visit participants will undergo 1 brief medical history and clinical examination 2 full pulmonary function tests 3 proton MRI 4 HP 129Xe MRI Qualified research team members will perform a clinical examination on the participant to record their vital statistics like age gender height weight heart rate respiratory rate oral temperature and blood pressure The QIdelegate during a brief conversation with the participant will collect relevant medical history from the participant to make sure the participant meets all the inclusionexclusion criteria for the study The QI will also make sure that the participant understands the study procedure and is willing to participate in the study At each study visit at SickKids the QI or delegate will also administer the QOL questionnaire to the participant Based on the clinical examination results medical history and the pulmonary function test results the QIdelegate will determine if all the inclusionexclusion criteria are met to proceed with the MRI part of the study visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None