Lung DiseasesNCT05998707
The Application of the New Magnetic Resonance UTE Technique in Thoracic Lesions
An observational study of Lung Diseases, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 13 Jun 2024
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People who meet the inclusion criteria.
Who may be able to join
- Age ≥18 years old;
- There are lung lesions, and the solid component is ≥6mm;
- Chest CT plain scan or /+ enhanced examination within 4 weeks.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Radiography department
Zhuhai, Guangdong, 519000
Xiaojun Chen, +8615820587112, 422175400@qq.com
About this study
Official title: The Application of the New Magnetic Resonance Technique-UTE in Thoracic Lesions
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.
Read the detailed 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.
- Conditions
- Lung Diseases
- Keywords
- Lung mass, UTE, ZTE, nodule, MRI
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| benign group | benign lesions in the lung | |
| malignant group | malignant tumor in the lung |
What is being measured
The primary outcome is the main question the study is designed to answer.
proton density fat fraction (PDFF)
Determination of proton density fat fraction by magnetic resonance imaging
Measured: baseline (before surgery)
T2 relaxation rate
R2*
Measured: baseline (before surgery)
Magnetization Transfer Ratio (MTR)
Magnetization Transfer Ratio
Measured: baseline (before surgery)
Secondary outcomes (1)
Subjective rating
rating scale
Measured: baseline (before surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jul 2023
- Primary completion13 Jun 2024 (estimated)
- Study completion13 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaolin Li, Study director, Fifth Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998707
- Sponsor's protocol ID
- ZDWY.FSK.024
- Status last verified
- Jul 2023
- First submitted
- 2 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of the New Magnetic Resonance Technique-UTE in Thoracic Lesions
- ClinicalTrials.gov ID
- NCT05998707
- Acronym / sponsor ID
- ZDWY.FSK.024
- Conditions
- Lung Diseases
- Keywords
- Lung mass, UTE, ZTE, nodule, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 13 Jun 2024 (estimated)
- Study completion
- 13 Jun 2024 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| benign group | – | –benign lesions in the lung |
| malignant group | – | –malignant tumor in the lung |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who meet the inclusion criteria.
Key inclusion criteria (3 listed)
- Age ≥18 years old;
- There are lung lesions, and the solid component is ≥6mm;
- Chest CT plain scan or /+ enhanced examination within 4 weeks.
Key exclusion criteria (7 listed)
- There are metal implants in the corresponding parts of the chest;
- MRI contrast agent allergy;
- Claustrophobia;
- Pregnant women;
- High fever;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
proton density fat fraction (PDFF)
Time frame: baseline (before surgery)
Determination of proton density fat fraction by magnetic resonance imaging
T2 relaxation rate
Time frame: baseline (before surgery)
R2*
Magnetization Transfer Ratio (MTR)
Time frame: baseline (before surgery)
Magnetization Transfer Ratio
1 secondary outcome
Subjective rating
Time frame: baseline (before surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaolin Li study director
Fifth Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, run by Fifth Affiliated Hospital, Sun Yat-Sen University 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 3 inclusion and 7 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 21 Aug 2023. 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 Xiaojun Chen (+8615820587112, 422175400@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proton density fat fraction (PDFF) (time frame: baseline (before surgery)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2023.