NCT05998707

Brief 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.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

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

July 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2024

Completed
Last Updated

August 21, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

August 2, 2023

Last Update Submit

August 17, 2023

Conditions

Lung Diseases

Keywords

Lung mass, UTE, ZTE, nodule, MRI

Outcome Measures

Primary Outcomes (3)

  • proton density fat fraction (PDFF)

    Determination of proton density fat fraction by magnetic resonance imaging

    baseline (before surgery)

  • T2 relaxation rate

    R2\*

    baseline (before surgery)

  • Magnetization Transfer Ratio (MTR)

    Magnetization Transfer Ratio

    baseline (before surgery)

Secondary Outcomes (1)

  • Subjective rating

    baseline (before surgery)

Study Arms (2)

benign group

benign lesions in the lung

malignant group

malignant tumor in the lung

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People who meet the inclusion criteria.

You may qualify if:

  • Age ≥18 years old;
  • There are lung lesions, and the solid component is ≥6mm;
  • Chest CT plain scan or /+ enhanced examination within 4 weeks.

You may not qualify if:

  • There are metal implants in the corresponding parts of the chest;
  • MRI contrast agent allergy;
  • Claustrophobia;
  • Pregnant women;
  • High fever;
  • Respiratory failure;
  • Lung lesion biopsy within 4 weeks prior to examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiography department

Zhuhai, Guangdong, 519000, China

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Shaolin Li

    Fifth Affiliated Hospital, Sun Yat-Sen University

    STUDY DIRECTOR

Central Study Contacts

Xiaojun Chen

CONTACT

+8615820587112422175400@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 21, 2023

Study Start

July 1, 2023

Primary Completion

June 13, 2024

Study Completion

June 13, 2024

Last Updated

August 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)