- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02976935
Functional MR Lung Imaging Using Hyperpolarised 129Xe
December 21, 2022 updated by: University of Nottingham
FUNCTIONAL MAGNETIC RESONANCE LUNG IMAGING USING INHALED HYPERPOLARISED 129Xe
The aim of this study is to investigate the potential value of a novel imaging technique (hyperpolarized 129Xe lung imaging) in the diagnosis and assessment of lung disease in patients with COPD and IPF.
Study Overview
Study Type
Observational
Enrollment (Actual)
53
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nottingham, United Kingdom, NG7 2UH
- Hyperpolarised Imaging Lung Facility, QMC, Uni of Nottingham
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy Volunteers, COPD
Description
General Inclusion criteria
- Male or Female aged over 18 years.
- Capacity to give informed consent
- Normal blood pressure (systolic BP > 100 mmHg and diastolic BP > 70 mmHg)
- Resting heart rate > 50 bpm
- For women, negative urinary β-hCG at the screening and subsequent visits
- Subject able to hold breath for 10 seconds
- Subject able to fit into 129Xe chest coil used for MRI
- Subject able to understand the requirements of the study and to cooperate with the study procedures
Inclusion criteria
HEALTHY VOLUNTEERS
• No significant respiratory disease within the last year
PATIENTS
COPD
- Evidence of airflow obstruction (FEV/FVC <0.7) and FEV1 <80% predicted post bronchodilator
- Minimum FVC 1.5L
Exclusion criteria
HEALTHY VOLUNTEERS
- Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
- Acute respiratory illness within 30 days of MRI
- Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
- Subject deemed unlikely to comply with instructions during imaging
- Do not meet the inclusion criteria above
- Subject not deemed fit enough to tolerate procedure
- Subject deemed unsuitable by clinical investigator for other reasons
PATIENTS
- Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
- Acute respiratory illness within 30 days of MRI
- Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
- Subject deemed unlikely to comply with instructions during imaging
- Do not meet the inclusion criteria above
- Subject not deemed fit enough to tolerate procedure
- Subject deemed unsuitable by clinical investigator for other reasons
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy Volunteers
Subjects will receive 1L non-hyperpolarised 129Xenon to inhale.
Then:Subjects will inhale the first hyperpolarised 129Xenon calibration dose (up to 1L, which may be a mix of hyperpolarised 129Xenon and N2) and hold their breath while the MRI scan is performed.
Then:A further series of inhalations will be performed up to a maximum of 3 (maximum total exposure to hyperpolarised 129Xenon will be 3.6L).
Optional Study Visit #2:Identical to Study Visit 1 but with the further series of inhalations being up to a maximum of 4 (maximum total exposure to hyperpolarised 129Xenon will be 5L).Optional Study Visit #3: Identical to Study Visit 2 (maximum total exposure to hyperpolarised 129Xenon will be 5L)
|
Hyperpolarised 129 Xe to assess lung function
|
Chronic Obstructive Pulmonary Disease
Subjects will receive 1L bag of non-hyperpolarised 129Xenon to inhale.
Then:Subjects will inhale the first hyperpolarised 129Xenon calibration dose (up to 1L, which may be a mix of hyperpolarised 129Xenon and N2) and hold their breath for required time while the MRI scan is performed.Then:A further series of inhalations will be performed up to a maximum of 3 (maximum total exposure to hyperpolarised 129Xenon will be 3.6L).
Optional Study Visit #2: Identical to Study Visit 1 (maximum total exposure to hyperpolarised 129Xenon will be 3.6L)
|
Hyperpolarised 129 Xe to assess lung function
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acquisition of baseline data and images to investigate use of hp129Xe as a diagnostic tool
Time Frame: 4 years
|
i) Obtain baseline data for each group with matched clinical data (e.g.
pulmonary function tests) allowing comparison with existing clinical diagnostic techniques and also determining correlation with disease severity ii) Use the images obtained to set up standard sequencing protocols and define algorithms and inform power calculations for subsequent studies
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Collation of data regarding ability of participants to adhere to the study protocol
Time Frame: 4 years
|
1) To collate data regarding the ability of participants of each group to adhere to the protocol thus informing the study design of future trials.
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
February 9, 2016
First Submitted That Met QC Criteria
November 24, 2016
First Posted (Estimate)
November 30, 2016
Study Record Updates
Last Update Posted (Actual)
December 22, 2022
Last Update Submitted That Met QC Criteria
December 21, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COPD
-
University Medical Center GroningenCompleted
-
Istituto Nazionale di Ricovero e Cura per AnzianiRecruiting
-
Bio-Sensing Solutions S.L. (DyCare)Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Centre...Not yet recruiting
-
Sir Run Run Shaw HospitalRecruiting
-
University Hospital, BrestRecruiting
-
The First Affiliated Hospital of Guangzhou Medical...Recruiting
-
Association des Réseaux BronchioliteLaboratoire Système et Matériaux pour la Mécatronique (SYMME)Recruiting
-
Baylor Research InstituteNot yet recruiting
-
Polytechnic Institute of PortoNippon Gases PortugalRecruiting
Clinical Trials on hyperpolarised 129 Xenon
-
Children's Hospital Medical Center, CincinnatiRecruitingRespiratory DisordersUnited States
-
Children's Hospital Medical Center, CincinnatiRecruitingRespiratory DisordersUnited States
-
University of VirginiaDuke UniversityRecruiting
-
Sheffield Teaching Hospitals NHS Foundation TrustCompleted
-
Children's Hospital of PhiladelphiaRecruitingThoracic Insufficiency SyndromeUnited States
-
Thunder Bay Regional Health Research InstituteLakehead University; Thunder Bay Regional Health Sciences CentreRecruitingAlzheimer DiseaseCanada
-
University of AarhusAarhus University HospitalNot yet recruitingProgressive Fibrosing Interstitial Lung DiseaseDenmark
-
Western University, CanadaUniversité de MontréalCompletedPreterm Birth | Bronchopulmonary DysplasiaCanada
-
Thunder Bay Regional Health Research InstituteNOAMAWithdrawnNon Small Cell Lung Cancer | Radiation Induced Lung Injury
-
Hamilton Health Sciences CorporationUnknownBronchiolitis ObliteransCanada