Breast MassesNCT06908291
Photoacoustic/Ultrasound Imaging for Breast Nodule Diagnosis, Molecular Classification, and Neoadjuvant Chemotherapy Response Evaluation
A study testing Multi-modal photoacoustic/ultrasonic (PA/US) imaging system in people with Breast Masses and Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Photoacoustic (PA) imaging (PAI) emergerd as a rapidly evolving biomedical imaging modality, which combines the merits of optical imaging and ultrasound (US) imaging, and has a capacity in morphological, functional and molecular imaging, showing potential in visualizing superficial organs. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Masses, Breast Cancer, Breast Cancer Treated with Neoadjuvant Chemotherapy
- What is being tested?
- Multi-modal photoacoustic/ultrasonic (PA/US) imaging system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patients were above 18 years-old;
- The patients were presented with a breast tumor, which were clearly shown on routine ultrasound; Biopsy or surgery of breast lesions was performed within 1 week and pathological diagnosis was obtained.
- Patients agreed to participate in this experiment and signed the Subject Informed Consent.
Who cannot join
- Pregnant or lactating women;
- Breast inflammation or local external injury;
- The breast mass has been excised for biopsy.
- Poor photoacoustic imaging effect.
- Deep lesion location (>3.5 cm)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Meng Yang, Doctor, 8601069155493, yangmeng_pumch@126.com
About this study
Official title: A Cohort Study on the Development of a Standardized Scoring System for Breast Nodule Differential Diagnosis, Molecular Classification, and Neoadjuvant Chemotherapy Evaluation Using Photoacoustic/Ultrasound Imaging
Photoacoustic (PA) imaging (PAI) emergerd as a rapidly evolving biomedical imaging modality, which combines the merits of optical imaging and ultrasound (US) imaging, and has a capacity in morphological, functional and molecular imaging, showing potential in visualizing superficial organs. The goal of this clinical trial is to build a PAI standardized scoring system to identify benign and malignant tumors, and use PAI to further determine the molecular classification of malignant breast tumors, and monitor the efficacy of neoadjuvant chemotherapy (NAC) in breast cancer. The main questions it aims to answer are:
- How to build a standardized PA/US scoring system in differential diagnosis of benign and malignant tumors?
- Can PAI precisely determine the molecular classification of breast tumors?
- Can PAI systems predict the efficacy of NAC in breast cancer?
Participants will receive regular PA/US imaging examinations during four stages of NAC (before NAC, 2 Cycles, 4 Cycles and 6 Cycles). And the effectiveness of PA/US in predicting NAC for breast cancer at different time points will be evaluated.
Read the detailed description
The multi-modality PA/US imaging system was built on a high-end commercial US platform and allowed real-time imaging of grey-scale US imaging, Color-Doppler US (CDUS) imaging and dual-wavelength PAI. The PA/US images were acquired using a hand-held probe integrated optical devices and US transducers. Researchers plan to recruit participants planning to undergo breast nodular surgery from the outpatient department of breast surgery in Peking Union Medical College Hospital. The patients are scheduled to receive multi-modality imaging examinations using the novel imaging system. First, conventional US scanning of the breast, including grey-scale US and CDUS, will be carried out by an experienced US operator. Afterwards, PA/US imaging will be implemented for breasts by the same operator. And the conventional ultrasound and photoacoustic information of the tumor will be assessed, including the tumor size, shape, boundary, calcificaition condition, the tumor blood flow and blood oxygenation. This clinical trial aims to address three key objectives: the development of a standardized PAI scoring system for distinguishing benign from malignant tumors, the application of PAI to assess the molecular classification of malignant breast tumors, and the use of PAI to monitor the efficacy of neoadjuvant chemotherapy (NAC) in breast cancer.
- Being tested
- Multi-modal photoacoustic/ultrasonic (PA/US) imaging system
- Keywords
- Breast cancer, neoadjuvant chemotherapy, photoacoustic imaging, multi-modality imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-modal photoacoustic/ultrasonic (PA/US) imaging systemDiagnostic test
The multi-modal PA/US imaging system is equipped with a handheld PA/US probe, and able to provide data of dual-wavelength PA imaging of breat tomor and Ipsilateral axillary lymph nodes, in addition to real-time 2D PA/US imaging.
| Study group | Role | What they receive |
|---|---|---|
| Breast nodules diagnosis cohort based on PA/US imaging | Experimental | Build a photoacoustic (PA) imaging (PAI) standardized scoring system to identify benign and malignant tumors, and use PAI to further determine the molecular classification of malignant breast tumors Receives: Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging system |
| Participants with breast cancer planning to undergo NAC based on PA/US imaging | Experimental | Patients over 18 years of age with histopathologically confirmed breast cancer with clinical stage T2 or above (≥20 mm in diameter) and/or lymph node positivity and plan to undergo neoadjuvant chemotherapy. Receives: Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish Photoacoustic/Ultrasound Standardized Scoring System for Differentiating Benign and Malignant Breast Masses
In this study, 300 patients who planned to undergo breast nodule surgery were enrolled. Tumor size, shape, boundary, calcification condition, peripheral vascular morphology, blood oxygen saturation (SO2), internal blood flow richness, blood oxygen semi-quantitative score will be measured in the standardized scoring system, and these photoacoustic and ultrasound parameters will be used to classify the mass as benign or malignant.
Measured: From enrollment to the end of treatment at 2 year
Predict the Precise Molecular Subtypes of Malignant Breast Masses Using Photoacoustic/Ultrasound Parameters
In this study, the same cohort as the first one will be used. Tumor size, shape, boundary, calcification condition, peripheral vascular morphology, blood oxygen saturation (SO2), internal blood flow richness, blood oxygen semi-quantitative score will be measured, and these photoacoustic and ultrasound parameters will be used to predict the precise molecular subtypes of malignant breast masses.
Measured: From enrollment to the end of treatment at 2 years
Evaluate Tumor Residual and Lymph Node Burden in Breast Cancer after Neoadjuvant Therapy
This study included 250 breast cancer patients confirmed by needle bioposy, with clinical stage T2 or above (diameter ≥20 mm) and/or with positive lymph nodes, who were to undergo neoadjuvant chemotherapy. Tumor size, shape, boundary, calcification condition, vascular richness, vascular morphology, blood oxygen saturation will be measured as indicators to predict pathological complete response (pCR).
Measured: From enrollment to the end of treatment at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start12 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast MassesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908291
- Sponsor's protocol ID
- PA/US Breast Tumor
- Status last verified
- Dec 2024
- First submitted
- 12 Jan 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study on the Development of a Standardized Scoring System for Breast Nodule Differential Diagnosis, Molecular Classification, and Neoadjuvant Chemotherapy Evaluation Using Photoacoustic/Ultrasound Imaging
- ClinicalTrials.gov ID
- NCT06908291
- Acronym / sponsor ID
- PA/US Breast Tumor
- Keywords
- Breast cancer, neoadjuvant chemotherapy, photoacoustic imaging, multi-modality imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Apr 2025 (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.
Photoacoustic (PA) imaging (PAI) emergerd as a rapidly evolving biomedical imaging modality, which combines the merits of optical imaging and ultrasound (US) imaging, and has a capacity in morphological, functional and molecular imaging, showing potential in visualizing superficial organs. The goal of this clinical trial is to build a PAI standardized scoring system to identify benign and malignant tumors, and use PAI to further determine the molecular classification of malignant breast tumors, and monitor the efficacy of neoadjuvant chemotherapy (NAC) in breast cancer. The main questions it aims to answer are:
- How to build a standardized PA/US scoring system in differential diagnosis of benign and malignant tumors?
- Can PAI precisely determine the molecular classification of breast tumors?
- Can PAI systems predict the efficacy of NAC in breast cancer?
Participants will receive regular PA/US imaging examinations during four stages of NAC (before NAC, 2 Cycles, 4 Cycles and 6 Cycles). And the effectiveness of PA/US in predicting NAC for breast cancer at different time points will be evaluated.
Detailed description
The multi-modality PA/US imaging system was built on a high-end commercial US platform and allowed real-time imaging of grey-scale US imaging, Color-Doppler US (CDUS) imaging and dual-wavelength PAI. The PA/US images were acquired using a hand-held probe integrated optical devices and US transducers. Researchers plan to recruit participants planning to undergo breast nodular surgery from the outpatient department of breast surgery in Peking Union Medical College Hospital. The patients are scheduled to receive multi-modality imaging examinations using the novel imaging system. First, conventional US scanning of the breast, including grey-scale US and CDUS, will be carried out by an experienced US operator. Afterwards, PA/US imaging will be implemented for breasts by the same operator. And the conventional ultrasound and photoacoustic information of the tumor will be assessed, including the tumor size, shape, boundary, calcificaition condition, the tumor blood flow and blood oxygenation. This clinical trial aims to address three key objectives: the development of a standardized PAI scoring system for distinguishing benign from malignant tumors, the application of PAI to assess the molecular classification of malignant breast tumors, and the use of PAI to monitor the efficacy of neoadjuvant chemotherapy (NAC) in breast cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast nodules diagnosis cohort based on PA/US imaging | Experimental | Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging systemBuild a photoacoustic (PA) imaging (PAI) standardized scoring system to identify benign and malignant tumors, and use PAI to further determine the molecular classification of malignant breast tumors |
| Participants with breast cancer planning to undergo NAC based on PA/US imaging | Experimental | Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging systemPatients over 18 years of age with histopathologically confirmed breast cancer with clinical stage T2 or above (≥20 mm in diameter) and/or lymph node positivity and plan to undergo neoadjuvant chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patients were above 18 years-old;
- The patients were presented with a breast tumor, which were clearly shown on routine ultrasound; Biopsy or surgery of breast lesions was performed within 1 week and pathological diagnosis was obtained.
- Patients agreed to participate in this experiment and signed the Subject Informed Consent.
Key exclusion criteria (5 listed)
- Pregnant or lactating women;
- Breast inflammation or local external injury;
- The breast mass has been excised for biopsy.
- Poor photoacoustic imaging effect.
- Deep lesion location (>3.5 cm)
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 |
|---|---|---|
| Multi-modal photoacoustic/ultrasonic (PA/US) imaging systemThe multi-modal PA/US imaging system is equipped with a handheld PA/US probe, and able to provide data of dual-wavelength PA imaging of breat tomor and Ipsilateral axillary lymph nodes, in addition to real-time 2D PA/US imaging. | Diagnostic test | Breast nodules diagnosis cohort based on PA/US imaging, Participants with breast cancer planning to undergo NAC based on PA/US imaging |
Primary outcome
Establish Photoacoustic/Ultrasound Standardized Scoring System for Differentiating Benign and Malignant Breast Masses
Time frame: From enrollment to the end of treatment at 2 year
In this study, 300 patients who planned to undergo breast nodule surgery were enrolled. Tumor size, shape, boundary, calcification condition, peripheral vascular morphology, blood oxygen saturation (SO2), internal blood flow richness, blood oxygen semi-quantitative score will be measured in the standardized scoring system, and these photoacoustic and ultrasound parameters will be used to classify the mass as benign or malignant.
Predict the Precise Molecular Subtypes of Malignant Breast Masses Using Photoacoustic/Ultrasound Parameters
Time frame: From enrollment to the end of treatment at 2 years
In this study, the same cohort as the first one will be used. Tumor size, shape, boundary, calcification condition, peripheral vascular morphology, blood oxygen saturation (SO2), internal blood flow richness, blood oxygen semi-quantitative score will be measured, and these photoacoustic and ultrasound parameters will be used to predict the precise molecular subtypes of malignant breast masses.
Evaluate Tumor Residual and Lymph Node Burden in Breast Cancer after Neoadjuvant Therapy
Time frame: From enrollment to the end of treatment at 3 years
This study included 250 breast cancer patients confirmed by needle bioposy, with clinical stage T2 or above (diameter ≥20 mm) and/or with positive lymph nodes, who were to undergo neoadjuvant chemotherapy. Tumor size, shape, boundary, calcification condition, vascular richness, vascular morphology, blood oxygen saturation will be measured as indicators to predict pathological complete response (pCR).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-modal photoacoustic/ultrasonic (PA/US) imaging system in people with Breast Masses and Breast Cancer, run by Peking Union Medical College Hospital 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 5 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: looking for participants now, as of the sponsor's last update on 3 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meng Yang, Doctor (8601060155493 ext. 8601060155493, yangmeng_pumch@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish Photoacoustic/Ultrasound Standardized Scoring System for Differentiating Benign and Malignant Breast Masses (time frame: From enrollment to the end of treatment at 2 year). 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 3 Apr 2025.