Breast Cancer FemaleNCT06468566
Identification of Benign and Malignant Breast Nodules Using Ultrasound-modulated Optical Tomography: A Multicenter Study
An observational study of Breast Cancer Female, run by Xin-Wu Cui at 1 site in China.
Trial summary
Ultrasonic light scattering imaging is a new functional imaging technology that combines traditional B-mode ultrasound imaging and light scattering tomography (DOT). It can improve the accuracy of early diagnosis of breast cancer based on the characteristics of abnormal blood supply and oxygen consumption of lesions. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Ultrasound light scattering imaging equipment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 28 Feb 2026
- 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 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: In order to verify that ultrasound light scattering imaging technology can help in the differential diagnosis of benign and malignant breast nodules. For subjects who meet the inclusion criteria, breast nodules will be examined by traditional ultrasound and ultrasonic light scattering imaging, and the diagnostic efficacy of both will be determined based on the final pathological results of the subjects.
Who may be able to join
- Had breast lesions detected by ultrasound Age 18 or older Upcoming FNAB or surgery Signing informed consent
Who cannot join
- Patients who had received a biopsy of breast lesion before the ultrasound examination Can not cooperate with the test operation Patients who were pregnant or lactating Patients who were undergoing neoadjuvant treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xin-Wu Cui
Wuhan, Hubei, 430030
Xin-Wu Cui, PhD,MD, 15927103161, cuixinwu@live.cn
About this study
Official title: Identification of Benign and Malignant Breast Nodules Using Opalogram Ultrasonography: A Multicenter Study
Ultrasonic light scattering imaging is a new functional imaging technology that combines traditional B-mode ultrasound imaging and light scattering tomography (DOT). It can improve the accuracy of early diagnosis of breast cancer based on the characteristics of abnormal blood supply and oxygen consumption of lesions. This study aims to evaluate the value of ultrasonic light scattering imaging in the differential diagnosis of benign and malignant breast nodules, and to evaluate the consistency between ultrasonic light scattering imaging and examiners in the differential diagnosis of benign and malignant breast nodules.
Read the detailed description
Breast cancer is the most common malignant tumor in women and the second leading cause of cancer death worldwide. Therefore, early detection and timely treatment of breast cancer are of great significance to controlling and reducing breast cancer mortality. Breast ultrasound has been widely used in the detection of breast cancer, but ultrasound is highly dependent on the examiner in terms of technology, and the examination results are greatly affected by the examiner's subjectivity, which increases unnecessary surgery and punctures, causing great trouble to clinicians and patients. Moreover, the value of conventional ultrasound in the differential diagnosis of breast masses is still limited, while the emergence of new technologies such as artificial intelligence and elastic imaging has improved the accuracy of ultrasound diagnosis to varying degrees.
The recently developed ultrasound light scattering imaging technology is used in breast ultrasound imaging systems to assist in morphological analysis based on the description and final evaluation of the Breast Imaging Reporting and Data System (BI-RADS), providing a new way to distinguish benign and malignant breast nodules.
Ultrasonic light scattering imaging technology is a new functional imaging technology that integrates traditional B-type ultrasound imaging and light scattering tomography (DOT). It uses B-type ultrasound to locate lesions and uses DOT to measure the concentrations of total hemoglobin, oxygenated hemoglobin and deoxygenated hemoglobin in diseased tissues based on the differences in the absorption rates of light of specific wavelengths in different tissues. It also measures the neovascularization at the tumor site and its potential local hypoxia stimulation. It introduces additional physiological information to current breast screening methods, often before morphological abnormalities. It can improve the accuracy of early diagnosis of breast cancer based on the characteristics of abnormal blood supply and oxygen consumption in lesions.
- Conditions
- Breast Cancer Female
- Being tested
- Ultrasound light scattering imaging equipment
- Keywords
- Ultrasonic light scattering imaging, Breast Cancer, Metastasis, Artificial intelligence
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound light scattering imaging equipmentDiagnostic test
Radiologists use ultrasound light scattering imaging to evaluate the benign and malignant nature of breast nodules
| Study group | Role | What they receive |
|---|---|---|
| Whether to use ultrasound light scattering imaging equipment | Not described Receives: Diagnostic Test: Ultrasound light scattering imaging equipment | |
| Conventional ultrasound | Not described | |
| Device Assistant physician | Not described Receives: Diagnostic Test: Ultrasound light scattering imaging equipment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benign breast tumor
Pathological diagnosis
Measured: Up to 12 months
Malignant breast tumor
Pathological diagnosis
Measured: Up to 12 months
Breast lymph node metastasis
Pathological diagnosis
Measured: Up to 12 months
No lymph node metastasis
Pathological diagnosis
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Feb 2024
- Primary completion30 Jan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xin-Wu Cui
- Sponsor type
- University, hospital or other
- Collaborators
- Hubei Cancer Hospital, Guangxi National Hospital, First Affiliated Hospital of Kunming Medical University
- Responsible party
- Sponsor-investigator, Xin-Wu Cui, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468566
- Sponsor's protocol ID
- 2024(S044)
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang Y, Cua M, Brake J, Liu Y, Yang C. Investigating ultrasound-light interaction in scattering media. J Biomed Opt. 2020 Feb;25(2):1-12. doi: 10.1117/1.JBO.25.2.025002.
PubMed 32103649Di Sciacca G, Maffeis G, Farina A, Dalla Mora A, Pifferi A, Taroni P, Arridge S. Evaluation of a pipeline for simulation, reconstruction, and classification in ultrasound-aided diffuse optical tomography of breast tumors. J Biomed Opt. 2022 Mar;27(3):036003. doi: 10.1117/1.JBO.27.3.036003.
PubMed 35332743Zhu Q, Ricci A Jr, Hegde P, Kane M, Cronin E, Merkulov A, Xu Y, Tavakoli B, Tannenbaum S. Assessment of Functional Differences in Malignant and Benign Breast Lesions and Improvement of Diagnostic Accuracy by Using US-guided Diffuse Optical Tomography in Conjunction with Conventional US. Radiology. 2016 Aug;280(2):387-97. doi: 10.1148/radiol.2016151097. Epub 2016 Mar 2.
PubMed 26937708
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Benign and Malignant Breast Nodules Using Opalogram Ultrasonography: A Multicenter Study
- ClinicalTrials.gov ID
- NCT06468566
- Acronym / sponsor ID
- 2024(S044)
- Conditions
- Breast Cancer Female
- Keywords
- Ultrasonic light scattering imaging, Breast Cancer, Metastasis, Artificial intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Xin-Wu CuiUniversity, hospital or other
- Collaborators
- Hubei Cancer Hospital, Guangxi National Hospital, First Affiliated Hospital of Kunming Medical University
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 21 Jun 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.
Ultrasonic light scattering imaging is a new functional imaging technology that combines traditional B-mode ultrasound imaging and light scattering tomography (DOT). It can improve the accuracy of early diagnosis of breast cancer based on the characteristics of abnormal blood supply and oxygen consumption of lesions. This study aims to evaluate the value of ultrasonic light scattering imaging in the differential diagnosis of benign and malignant breast nodules, and to evaluate the consistency between ultrasonic light scattering imaging and examiners in the differential diagnosis of benign and malignant breast nodules.
Detailed description
Breast cancer is the most common malignant tumor in women and the second leading cause of cancer death worldwide. Therefore, early detection and timely treatment of breast cancer are of great significance to controlling and reducing breast cancer mortality. Breast ultrasound has been widely used in the detection of breast cancer, but ultrasound is highly dependent on the examiner in terms of technology, and the examination results are greatly affected by the examiner's subjectivity, which increases unnecessary surgery and punctures, causing great trouble to clinicians and patients. Moreover, the value of conventional ultrasound in the differential diagnosis of breast masses is still limited, while the emergence of new technologies such as artificial intelligence and elastic imaging has improved the accuracy of ultrasound diagnosis to varying degrees.
The recently developed ultrasound light scattering imaging technology is used in breast ultrasound imaging systems to assist in morphological analysis based on the description and final evaluation of the Breast Imaging Reporting and Data System (BI-RADS), providing a new way to distinguish benign and malignant breast nodules.
Ultrasonic light scattering imaging technology is a new functional imaging technology that integrates traditional B-type ultrasound imaging and light scattering tomography (DOT). It uses B-type ultrasound to locate lesions and uses DOT to measure the concentrations of total hemoglobin, oxygenated hemoglobin and deoxygenated hemoglobin in diseased tissues based on the differences in the absorption rates of light of specific wavelengths in different tissues. It also measures the neovascularization at the tumor site and its potential local hypoxia stimulation. It introduces additional physiological information to current breast screening methods, often before morphological abnormalities. It can improve the accuracy of early diagnosis of breast cancer based on the characteristics of abnormal blood supply and oxygen consumption in lesions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whether to use ultrasound light scattering imaging equipment | – | Diagnostic Test: Ultrasound light scattering imaging equipment |
| Conventional ultrasound | – | – |
| Device Assistant physician | – | Diagnostic Test: Ultrasound light scattering imaging equipment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In order to verify that ultrasound light scattering imaging technology can help in the differential diagnosis of benign and malignant breast nodules. For subjects who meet the inclusion criteria, breast nodules will be examined by traditional ultrasound and ultrasonic light scattering imaging, and the diagnostic efficacy of both will be determined based on the final pathological results of the subjects.
Key inclusion criteria (1 listed)
- Had breast lesions detected by ultrasound Age 18 or older Upcoming FNAB or surgery Signing informed consent
Key exclusion criteria (1 listed)
- Patients who had received a biopsy of breast lesion before the ultrasound examination Can not cooperate with the test operation Patients who were pregnant or lactating Patients who were undergoing neoadjuvant treatment.
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 |
|---|---|---|
| Ultrasound light scattering imaging equipmentRadiologists use ultrasound light scattering imaging to evaluate the benign and malignant nature of breast nodules | Diagnostic test | Device Assistant physician, Whether to use ultrasound light scattering imaging equipment |
Primary outcome
Benign breast tumor
Time frame: Up to 12 months
Pathological diagnosis
Malignant breast tumor
Time frame: Up to 12 months
Pathological diagnosis
Breast lymph node metastasis
Time frame: Up to 12 months
Pathological diagnosis
No lymph node metastasis
Time frame: Up to 12 months
Pathological diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Background: PubMed 32103649Huang Y, Cua M, Brake J, Liu Y, Yang C. Investigating ultrasound-light interaction in scattering media. J Biomed Opt. 2020 Feb;25(2):1-12. doi: 10.1117/1.JBO.25.2.025002.
- Background: PubMed 35332743Di Sciacca G, Maffeis G, Farina A, Dalla Mora A, Pifferi A, Taroni P, Arridge S. Evaluation of a pipeline for simulation, reconstruction, and classification in ultrasound-aided diffuse optical tomography of breast tumors. J Biomed Opt. 2022 Mar;27(3):036003. doi: 10.1117/1.JBO.27.3.036003.
- Background: PubMed 26937708Zhu Q, Ricci A Jr, Hegde P, Kane M, Cronin E, Merkulov A, Xu Y, Tavakoli B, Tannenbaum S. Assessment of Functional Differences in Malignant and Benign Breast Lesions and Improvement of Diagnostic Accuracy by Using US-guided Diffuse Optical Tomography in Conjunction with Conventional US. Radiology. 2016 Aug;280(2):387-97. doi: 10.1148/radiol.2016151097. Epub 2016 Mar 2.
- 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.
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 Breast Cancer Female, run by Xin-Wu Cui 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 1 inclusion and 1 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 Jun 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 Xiao-Feng Zhang, PhD (18778035342, 562438747@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Benign breast tumor (time frame: Up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06468566, which also lists 3 linked publications.
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 Jun 2024.