NCT06431555

Brief 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 disease progression were explored.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 10, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

May 28, 2024

Status Verified

January 1, 2024

Enrollment Period

1.5 years

First QC Date

May 22, 2024

Last Update Submit

May 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • perfusion defect percentage

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

    12 months

Interventions

MRIDEVICE

Non-contrast, free-breathing MRI scan

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • (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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

Related Publications (1)

  • 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. 2025 Nov 24. doi: 10.1002/jmri.70183. Online ahead of print.

Study Officials

  • Shumin Wang, PhD

    Beijing Chao Yang Hospital

    STUDY DIRECTOR

Central Study Contacts

Tao Ouyang, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2024

First Posted

May 28, 2024

Study Start

January 10, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

May 28, 2024

Record last verified: 2024-01

Locations