- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06431555
Magnetic Resonance Lung Function Imaging Study of Pulmonary Fibrosis Combined With Emphysema Syndrome
May 22, 2024 updated by: Beijing Chao Yang Hospital
This study intends to use magnetic resonance pulmonary function imaging technology to explore imaging markers for early diagnosis of patients with CPFE.
Through baseline, 6-month and 12-month follow-up examinations, the changes in magnetic resonance pulmonary function in patients with CPFE and their correlation with disease progression were explored.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
55
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tao Ouyang, PhD
- Phone Number: +86 18720931226
- Email: ouyt1996@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100020
- Recruiting
- Beijing Chaoyang Hospital
-
Contact:
- Tao Ouyang, PhD
- Phone Number: +86 18720931226
- Email: ouyt1996@163.com
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
(1) Chest HRCT shows emphysema mainly distributed in the upper lung field, manifesting as wallless or thin-walled (wall thickness <1 mm) low-transmittance areas with clear boundaries with normal tissue, or multiple bullae (diameter > 1 cm), and the emphysema area/total lung volume is ≥10%; (2) interstitial pulmonary fibrosis mainly distributed in the lower lung field and subpleura, manifesting as honeycomb shadow or grid shadow, and the lung structure is destroyed , may be accompanied by traction bronchiectasis, ground glass opacities and consolidation opacities.
Description
Inclusion Criteria:
- (1) Chest HRCT shows emphysema mainly distributed in the upper lung field, manifesting as wallless or thin-walled (wall thickness <1 mm) low-transmittance areas with clear boundaries with normal tissue, or multiple bullae (diameter > 1 cm), and the emphysema area/total lung volume is ≥10%; (2) interstitial pulmonary fibrosis mainly distributed in the lower lung field and subpleura, manifesting as honeycomb shadow or grid shadow, and the lung structure is destroyed , may be accompanied by traction bronchiectasis, ground glass opacities and consolidation opacities.
Exclusion Criteria:
- (1) Refusal to sign the informed consent form; (2) MRI contraindications (implanted pacemaker/defibrillator, claustrophobia, or any clinical condition that prohibits longer MRI examinations).
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
perfusion defect percentage
Time Frame: 12 months
|
Calculate MRI lung perfusion defect as a percentage of the whole lung
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Shumin Wang, PhD, Beijing Chao Yang Hospital
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 (Actual)
January 10, 2024
Primary Completion (Estimated)
June 30, 2025
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
May 22, 2024
First Submitted That Met QC Criteria
May 22, 2024
First Posted (Actual)
May 28, 2024
Study Record Updates
Last Update Posted (Actual)
May 28, 2024
Last Update Submitted That Met QC Criteria
May 22, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-ke-107
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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