Breast CancerMIES-BCNATNCT04661436
Multimodal Imaging Evaluation System of Axillary Lymph Node Staging and Treatment Strategy for Breast Cancer Neoadjuvant Therapy
An observational study of Breast Cancer, run by Sichuan Provincial People's Hospital.
Trial summary
In view of the lack of systematic curative effect prediction and early evaluation indicators for breast cancer neoadjuvant chemotherapy, the effective fusion of CEUS（contrast-enhanced ultrasound） and MRI is realized, and a multi-modal standardized evaluation system of NAT based on the dynamics across time and full… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Contrast-Enhanced Ultrasound
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 31 Dec 2023
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Invasive breast cancer confirmed by preoperative biopsy pathological examination, clinical stage is II-III.
Who may be able to join
- Age and gender: 18 to 70 years old, female;
- ECOG systemic state 0~1;
- Screening examinations, including medical history, vital signs measurement, general physical examination, laboratory examinations (blood routine, urine routine, blood biochemistry, blood electrolytes, full set of pre-transfusion, etc.), electrocardiogram, heart and abdomen color Doppler ultrasound, head, chest, Abdominal CT and bone scan to determine whether the subjects are in good health and have distant metastases;
- According to the RECIST1.1 standard, at least one measurable lesion exists;
- Invasive breast cancer confirmed by preoperative biopsy pathological examination, clinical stage is II-III [cT2 and any N, cT3 and any N; cT4 and any N, according to the American Joint Committee on Cancer (AJCC) standard] Breast cancer patients;
- The functional level of organs must meet the following requirements:
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- Blood routine ANC≥1.5×10 9/L; PLT≥90×10 9/L; Hb≥90 g/L;
- Blood biochemistry TBIL≤1.5×ULN; ALT and AST≤2×ULN; BUN and Cr ≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula);
- Heart color Doppler ultrasound LVEF≥50%;
- 12-lead ECG Fridericia method corrected QT interval (QTcF) female <470 ms.
- Patients with known hormone receptor status.
- Patients with negative serum pregnancy tests and patients with reproductive potential must agree to use effective non-hormonal contraceptive methods during treatment and at least 6 months after the last use of the test drug.
- During the trial period and within 6 months after the trial, female subjects should take medically acceptable or reliable contraceptive measures;
- Subjects understand the test procedures, voluntarily comply with the requirements of the test protocol, and agree to participate in the test by signing an informed consent form approved by the ethics committee of the participating center.
Who cannot join
- Allergic physique, those who are known to be allergic to the components of the test drug (inquiry); those who have a history of allergies to ultrasound contrast agents (sulfur hexafluoride microbubbles) and any contrast agent in enhanced magnetic resonance (inquiry) ；
- Inflammatory breast cancer; metastatic breast cancer (stage IV)
- A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency and a history of organ transplantation;
- Have ever suffered from any heart disease, including: 1) angina pectoris; 2) arrhythmia requiring medication or clinical significance; 3) myocardial infarction; 4) heart failure; 5) any person judged to be unsuitable Other heart diseases participating in this trial.
- Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period.
- According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.).
- Have a clear history of neurological or mental disorders, including epilepsy or dementia.
- Any other situation that the researcher considers inappropriate to participate in this research.
Trial locations and contacts
No sites are listed yet.
About this study
In view of the lack of systematic curative effect prediction and early evaluation indicators for breast cancer neoadjuvant chemotherapy, the effective fusion of CEUS（contrast-enhanced ultrasound） and MRI is realized, and a multi-modal standardized evaluation system of NAT based on the dynamics across time and full cycle is constructed, in order to find the predictive effect and early evaluation of NAT. Means to improve the accuracy of NAT patient selection, treatment course selection, and efficacy evaluation, to achieve controllable and individualized and precise NAT, thereby improving efficacy, reducing unnecessary treatment adverse reactions, guiding pathological materials, reducing medical costs, and ultimately improving breast cancer The patient's DFS and OS. In addition, for patients with axillary lymph node cN0 before and after neoadjuvant or descending after neoadjuvant, the evaluation system is used to explore the feasibility, safety, and effectiveness of replacing sentinel lymph node biopsy or carrying out sentinel lymph node biopsy, which is a useful strategy for axillary lymph node management in such patients. Develop a theoretical foundation.
- Conditions
- Breast Cancer
- Being tested
- Contrast-Enhanced Ultrasound
- Keywords
- Breast cancer, axillary lymph nodes, neoadjuvant therapy, Evagination
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-Enhanced UltrasoundDiagnostic test
Also called Magnetic Resonance Imaging
The research will study the qualitative analysis indicators of contrast-enhanced ultrasound, including: enhancement uniformity, enhanced range, presence or absence of enhancement defect area, presence or absence of nourishing blood vessels, etc.; and quantitative analysis indicators, including: peak time, peak intensity, rising slope, Area under the curve, etc., analyze the correlation between the changes of various parameters before and after neoadjuvant treatment（NAT） and the pathological response of patients, and try to find indicators and cut-off values that can predict and early evaluate the efficacy.
This study will study the qualitative and quantitative parameters of MRI-enhanced scanning and the changes of DWI parameters, analyze the correlation between the parameters of patients before and after NAT and pathological response, and try to find indicators and cut-off values that can predict and early evaluate the efficacy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative analysis parameters and cut-off values of contrast-enhanced ultrasound prediction and early evaluation of NAT efficacy;
By studying the qualitative analysis indicators of contrast-enhanced ultrasound, including: enhancement uniformity, enhanced range, presence or absence of enhancement defect area, presence or absence of nourishing vessels, etc.; and quantitative analysis indicators, including: peak time, peak intensity, rising slope, under the curve Area, etc., analyze the correlation between the changes of the parameters before and after NAT and the pathological response.
Measured: Estimated up to 2 year
Enhanced MRI prediction and DWI for early evaluation of NAT efficacy, and enhanced quantitative analysis parameters and cut-off values
By studying the qualitative and quantitative parameters of MRI-enhanced scanning and the changes of DWI parameters, the correlation between the parameters before and after NAT and the pathological response of patients is analyzed.
Measured: Estimated up to 2 year
Able to predict and assess the stage of axillary lymph nodes after NAT and guide the development of diagnostic criteria for treatment strategies
Combining the high sensitivity of ultrasound in the recognition of superficial lymph nodes, the feasibility of contrast-enhanced ultrasound in the identification, location and diagnosis of sentinel lymph nodes in breast cancer, and the integrity of MRI, to discuss the formulation of multi-imaging systems for the treatment of axillary lymph nodes in patients with lymph node degeneration after NAT The feasibility, safety and effectiveness of clinical application.
Measured: Estimated up to 2 year
Construct a multi-modal and multi-parameter evaluation system and its standards that can predict and early evaluate the efficacy of NAT.
Based on the above three research results, a mathematical model is established, a multi-modal and multi-parameter evaluation system combining multiple images is constructed, and the strengths are complemented to establish an economic and efficient evaluation index system and standardized process.
Measured: Estimated up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Luo, Sichuan Provincial People's Hospital
- Investigators
- Jun Luo, Master, Principal investigator, Sichuan Provincial People's HospitalJie Chen, Master, Study director, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661436
- Sponsor's protocol ID
- MIES-BCNAT
- Acronym
- MIES-BCNAT
- Status last verified
- Dec 2020
- First submitted
- 3 Dec 2020
- Last updated
- 10 Dec 2020
- 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 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Imaging Evaluation System of Axillary Lymph Node Staging and Treatment Strategy for Breast Cancer Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT04661436
- Acronym / sponsor ID
- MIES-BCNAT / MIES-BCNAT
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, axillary lymph nodes, neoadjuvant therapy, Evagination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Dec 2020 (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.
In view of the lack of systematic curative effect prediction and early evaluation indicators for breast cancer neoadjuvant chemotherapy, the effective fusion of CEUS（contrast-enhanced ultrasound） and MRI is realized, and a multi-modal standardized evaluation system of NAT based on the dynamics across time and full cycle is constructed, in order to find the predictive effect and early evaluation of NAT. Means to improve the accuracy of NAT patient selection, treatment course selection, and efficacy evaluation, to achieve controllable and individualized and precise NAT, thereby improving efficacy, reducing unnecessary treatment adverse reactions, guiding pathological materials, reducing medical costs, and ultimately improving breast cancer The patient's DFS and OS. In addition, for patients with axillary lymph node cN0 before and after neoadjuvant or descending after neoadjuvant, the evaluation system is used to explore the feasibility, safety, and effectiveness of replacing sentinel lymph node biopsy or carrying out sentinel lymph node biopsy, which is a useful strategy for axillary lymph node management in such patients. Develop a theoretical foundation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Invasive breast cancer confirmed by preoperative biopsy pathological examination, clinical stage is II-III.
Key inclusion criteria (14 listed)
- Age and gender: 18 to 70 years old, female;
- ECOG systemic state 0~1;
- Screening examinations, including medical history, vital signs measurement, general physical examination, laboratory examinations (blood routine, urine routine, blood biochemistry, blood electrolytes, full set of pre-transfusion, etc.), electrocardiogram, heart and abdomen color Doppler ultrasound, head, chest, Abdominal CT and bone scan to determine whether the subjects are in good health and have distant metastases;
- According to the RECIST1.1 standard, at least one measurable lesion exists;
- Invasive breast cancer confirmed by preoperative biopsy pathological examination, clinical stage is II-III [cT2 and any N, cT3 and any N; cT4 and any N, according to the American Joint Committee on Cancer (AJCC) standard] Breast cancer patients;
Key exclusion criteria (8 listed)
- Allergic physique, those who are known to be allergic to the components of the test drug (inquiry); those who have a history of allergies to ultrasound contrast agents (sulfur hexafluoride microbubbles) and any contrast agent in enhanced magnetic resonance (inquiry) ；
- Inflammatory breast cancer; metastatic breast cancer (stage IV)
- A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency and a history of organ transplantation;
- Have ever suffered from any heart disease, including: 1) angina pectoris; 2) arrhythmia requiring medication or clinical significance; 3) myocardial infarction; 4) heart failure; 5) any person judged to be unsuitable Other heart diseases participating in this trial.
- Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period.
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 |
|---|---|---|
| Contrast-Enhanced UltrasoundAlso: Magnetic Resonance ImagingThe research will study the qualitative analysis indicators of contrast-enhanced ultrasound, including: enhancement uniformity, enhanced range, presence or absence of enhancement defect area, presence or absence of nourishing blood vessels, etc.; and quantitative analysis indicators, including: peak time, peak intensity, rising slope, Area under the curve, etc., analyze the correlation between the changes of various parameters before and after neoadjuvant treatment（NAT） and the pathological response of patients, and try to find indicators and cut-off values that can predict and early evaluate the efficacy. This study will study the qualitative and quantitative parameters of MRI-enhanced scanning and the changes of DWI parameters, analyze the correlation between the parameters of patients before and after NAT and pathological response, and try to find indicators and cut-off values that can predict and early evaluate the efficacy. | Diagnostic test | – |
Primary outcome
Quantitative analysis parameters and cut-off values of contrast-enhanced ultrasound prediction and early evaluation of NAT efficacy;
Time frame: Estimated up to 2 year
By studying the qualitative analysis indicators of contrast-enhanced ultrasound, including: enhancement uniformity, enhanced range, presence or absence of enhancement defect area, presence or absence of nourishing vessels, etc.; and quantitative analysis indicators, including: peak time, peak intensity, rising slope, under the curve Area, etc., analyze the correlation between the changes of the parameters before and after NAT and the pathological response.
Enhanced MRI prediction and DWI for early evaluation of NAT efficacy, and enhanced quantitative analysis parameters and cut-off values
Time frame: Estimated up to 2 year
By studying the qualitative and quantitative parameters of MRI-enhanced scanning and the changes of DWI parameters, the correlation between the parameters before and after NAT and the pathological response of patients is analyzed.
Able to predict and assess the stage of axillary lymph nodes after NAT and guide the development of diagnostic criteria for treatment strategies
Time frame: Estimated up to 2 year
Combining the high sensitivity of ultrasound in the recognition of superficial lymph nodes, the feasibility of contrast-enhanced ultrasound in the identification, location and diagnosis of sentinel lymph nodes in breast cancer, and the integrity of MRI, to discuss the formulation of multi-imaging systems for the treatment of axillary lymph nodes in patients with lymph node degeneration after NAT The feasibility, safety and effectiveness of clinical application.
Construct a multi-modal and multi-parameter evaluation system and its standards that can predict and early evaluate the efficacy of NAT.
Time frame: Estimated up to 2 year
Based on the above three research results, a mathematical model is established, a multi-modal and multi-parameter evaluation system combining multiple images is constructed, and the strengths are complemented to establish an economic and efficient evaluation index system and standardized process.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- 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.
Jun Luo, Master principal investigator
Sichuan Provincial People's Hospital
Jie Chen, Master study director
Sichuan Provincial People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Sichuan Provincial People's Hospital.
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 14 inclusion and 8 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 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Jun Luo, Master (17740209986, Milton-lj@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative analysis parameters and cut-off values of contrast-enhanced ultrasound prediction and early evaluation of NAT efficacy; (time frame: Estimated up to 2 year). 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?
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 10 Dec 2020.