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Using Functional Lung MRI to Explore Pulmonary Perfusion Changes in Patients With Pulmonary Fibrosis and Emphysema SyndromeNCT06431555

Magnetic Resonance Lung Function Imaging Study of Pulmonary Fibrosis Combined With Emphysema Syndrome

An observational study of Using Functional Lung MRI to Explore Pulmonary Perfusion Changes in Patients With Pulmonary Fibrosis and Emphysema Syndrome, run by Beijing Chao Yang Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
MRI
Type of treatment
Medical device
How many people
55 participants
Where
1 siteChina
Study dates
10 Jan 2024to 30 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • (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.

Who cannot join

  • (1) Refusal to sign the informed consent form; (2) MRI contraindications (implanted pacemaker/defibrillator, claustrophobia, or any clinical condition that prohibits longer MRI examinations).

Trial locations and contacts

1 site in 1 country.

Tao Ouyang, PhD contact

+86 18720931226

ouyt1996@163.com

China1 site, 1 recruiting
  • Beijing Chaoyang Hospital

    Beijing, Beijing Municipality, 100020

    Tao Ouyang, PhD, +86 18720931226, ouyt1996@163.com

    Recruiting

Other trials in China

About this study

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.

Being tested
MRI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRIDevice

    Non-contrast, free-breathing MRI scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. perfusion defect percentage

    Calculate MRI lung perfusion defect as a percentage of the whole lung

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2024
  2. Study start10 Jan 2024
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06431555
Sponsor's protocol ID
2024-ke-107
Status last verified
Jan 2024
First submitted
22 May 2024
Last updated
28 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ouyang T, Wang Y, Zhang H, Voskrebenzev A, Vogel-Claussen J, Ye Q, Yang Q. Ventilation and Perfusion Defects on Phase-Resolved Functional Lung (PREFUL) MRI Predict Silicosis Progression: A Prospective Pilot Study. J Magn Reson Imaging. 2026 Apr;63(4):1177-1187. doi: 10.1002/jmri.70183. Epub 2025 Nov 24.

    PubMed 41277498

Questions about this trial

What is this clinical trial studying?

An observational study of Using Functional Lung MRI to Explore Pulmonary Perfusion Changes in Patients With Pulmonary Fibrosis and Emphysema Syndrome, run by Beijing Chao Yang Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tao Ouyang, PhD (+86 18720931226, ouyt1996@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

perfusion defect percentage (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06431555, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.

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