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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05998707
Other study ID # ZDWY.FSK.024
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2023
Est. completion date June 13, 2024

Study information

Verified date July 2023
Source Fifth Affiliated Hospital, Sun Yat-Sen University
Contact Xiaojun Chen
Phone +8615820587112
Email 422175400@qq.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Quantitative characteristic values of lung lesions were obtained by UTE technique, so as to make qualitative diagnosis of benign and malignant lesions. And to explore the clinical feasibility of CT-like technology - high resolution ZTE technology in the diagnosis of pulmonary diseases.


Description:

Ultrashort echo time (UTE) sequence can obtain data from T2* for lung imaging before T2* decays in lung parenchyma with extremely short echo time, which makes up for the defect that conventional MRI cannot clearly display short T2 tissue imaging, and can provide more supplementary information for lung CT scan. There has been a lot of research progress in the evaluation of neonatal lung disease, chronic obstructive airway disease and pneumonia. The 3D UTE sequence developed on this basis has made great progress in improving the resolution, signal-to-noise ratio and shortening the scanning time of lung MR Images, and has successfully obtained submillimeter high-resolution images. The purpose of this study was to explore the value of MRI ultra-short echo technology in the qualitative diagnosis of benign and malignant lung lesions, and to explore the clinical application of CT-like technology - high resolution ZTE technology in the lung.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date June 13, 2024
Est. primary completion date June 13, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age =18 years old; 2. There are lung lesions, and the solid component is =6mm; 3. Chest CT plain scan or /+ enhanced examination within 4 weeks. Exclusion Criteria: 1. There are metal implants in the corresponding parts of the chest; 2. MRI contrast agent allergy; 3. Claustrophobia; 4. Pregnant women; 5. High fever; 6. Respiratory failure; 7. Lung lesion biopsy within 4 weeks prior to examination.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Radiography department Zhuhai Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary proton density fat fraction (PDFF) Determination of proton density fat fraction by magnetic resonance imaging baseline (before surgery)
Primary T2 relaxation rate R2* baseline (before surgery)
Primary Magnetization Transfer Ratio (MTR) Magnetization Transfer Ratio baseline (before surgery)
Secondary Subjective rating rating scale baseline (before surgery)
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