Multimoda LultasoundNCT06530771
Multimodality US Based on Angio Planewave Ultrasensitive Imaging and Shear Wave Elastography to Evaluate the Malignancy Risk Value of Thyroid Nodules
An observational study of Multimoda Lultasound and Thyroid Cancer, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the value of a multimodal ultrasound model based on Angio Planewave Ultrasensitive Imaging, Shear Wave Elastography and grayscale ultrasound in the differential diagnosis of benign and malignant thyroid nodules. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multimoda Lultasound, Thyroid Cancer, Microvascular Classification
- What is being tested?
- ultrasound
- How many people
- 720 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Dec 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population data for this prospective single-center cohort study were gathered at the Fifth Affiliated Hospital of Sun Yat-sen University.
Who may be able to join
- age more than 18 years;
- Voluntarily signed informed consent;
- Have 1 or more thyroid nodules detectable by ultrasound;
- participant underwent surgical procedure to confirm the pathologic results
Who cannot join
- Nodules are accompanied by large calcifications followed by acoustic shadows
- History of previous neck surgery or cancer, thyroid medications, radiation or surgical treatment;
- Poor quality of retained images or non-standard operations (such as intermittent scanning and improper probe compression), and incomplete pathological results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, 519000
TianXin Lin, MD, +8613724008338
About this study
Official title: Multimodality US Based on Angio Planewave Ultrasensitive Imaging and Shear Wave Elastography to Guide the Fine-Needle Aspiration Management of Thyroid Lesions: Focus on the Innovative Microvascular Classification
The goal of this clinical trial is to explore the value of a multimodal ultrasound model based on Angio Planewave Ultrasensitive Imaging, Shear Wave Elastography and grayscale ultrasound in the differential diagnosis of benign and malignant thyroid nodules. The main questions it aims to answer are:
Can an innovative ultra-microvascular classification system based on Angio Planewave Ultrasensitive Imaging distinguish between benign and malignant thyroid nodules? How about the performance of multimodal ultrasound model to Guide the Fine-Needle Aspiration Management of Thyroid Lesions?
Read more
Participants will:
Undergo grayscale ultrasound, SWE, and Angio Planewave Ultrasensitive Imaging multimodal thyroid ultrasound examination within one week before surgery Undergo surgery and obtain the postoperative pathological diagnosis
- Being tested
- ultrasound
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDiagnostic test
Conventional US, SWE, and AP of thyroid nodules were conducted successively with a Supersonic Aixplorer system (SuperSonic Imagine, Aix-en-Provence, France) using a 5-14 MHz linear transducer.
| Study group | Role | What they receive |
|---|---|---|
| Malignant thyroid nodules | Not described Receives: Diagnostic Test: ultrasound | |
| Benign thyroid nodules | Not described Receives: Diagnostic Test: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficacy
the area under the receiver operating characteristic (ROC) curve (AUC)
Measured: one week
Diagnostic efficacy
sensitivity, specificity, accuracy
Measured: one week
positive predictive value (PPV), and negative predictive value (NPV)
Diagnostic efficacy
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Jul 2022
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multimoda LultasoundStudies 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
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530771
- Sponsor's protocol ID
- ZDWY.CSK.008
- Status last verified
- Dec 2023
- First submitted
- 29 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality US Based on Angio Planewave Ultrasensitive Imaging and Shear Wave Elastography to Guide the Fine-Needle Aspiration Management of Thyroid Lesions: Focus on the Innovative Microvascular Classification
- ClinicalTrials.gov ID
- NCT06530771
- Acronym / sponsor ID
- ZDWY.CSK.008
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 31 Jul 2024 (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.
The goal of this clinical trial is to explore the value of a multimodal ultrasound model based on Angio Planewave Ultrasensitive Imaging, Shear Wave Elastography and grayscale ultrasound in the differential diagnosis of benign and malignant thyroid nodules. The main questions it aims to answer are:
Can an innovative ultra-microvascular classification system based on Angio Planewave Ultrasensitive Imaging distinguish between benign and malignant thyroid nodules? How about the performance of multimodal ultrasound model to Guide the Fine-Needle Aspiration Management of Thyroid Lesions?
Participants will:
Undergo grayscale ultrasound, SWE, and Angio Planewave Ultrasensitive Imaging multimodal thyroid ultrasound examination within one week before surgery Undergo surgery and obtain the postoperative pathological diagnosis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malignant thyroid nodules | – | Diagnostic Test: ultrasound |
| Benign thyroid nodules | – | Diagnostic Test: ultrasound |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population data for this prospective single-center cohort study were gathered at the Fifth Affiliated Hospital of Sun Yat-sen University.
Key inclusion criteria (4 listed)
- age more than 18 years;
- Voluntarily signed informed consent;
- Have 1 or more thyroid nodules detectable by ultrasound;
- participant underwent surgical procedure to confirm the pathologic results
Key exclusion criteria (3 listed)
- Nodules are accompanied by large calcifications followed by acoustic shadows
- History of previous neck surgery or cancer, thyroid medications, radiation or surgical treatment;
- Poor quality of retained images or non-standard operations (such as intermittent scanning and improper probe compression), and incomplete pathological results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundConventional US, SWE, and AP of thyroid nodules were conducted successively with a Supersonic Aixplorer system (SuperSonic Imagine, Aix-en-Provence, France) using a 5-14 MHz linear transducer. | Diagnostic test | Benign thyroid nodules, Malignant thyroid nodules |
Primary outcome
Diagnostic efficacy
Time frame: one week
the area under the receiver operating characteristic (ROC) curve (AUC)
Diagnostic efficacy
Time frame: one week
sensitivity, specificity, accuracy
positive predictive value (PPV), and negative predictive value (NPV)
Time frame: one week
Diagnostic efficacy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: Undecided
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.
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 Multimoda Lultasound and Thyroid Cancer, 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 4 inclusion and 3 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 31 Jul 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 Xin Wen (15913232456, wenxin7@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic efficacy (time frame: one week). 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 31 Jul 2024; AzTrials last refreshed its copy on 1 Nov 2026.