Multimodal Imaging Evaluation System of Axillary Lymph Node Staging and Treatment Strategy for Breast Cancer Neoadjuvant Therapy (MIES-BCNAT)

December 3, 2020 updated by: Jun Luo, Sichuan Provincial People's Hospital
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Invasive breast cancer confirmed by preoperative biopsy pathological examination, clinical stage is II-III.

Description

Inclusion Criteria:

  1. Age and gender: 18 to 70 years old, female;
  2. ECOG systemic state 0~1;
  3. 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;
  4. According to the RECIST1.1 standard, at least one measurable lesion exists;
  5. 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;

  6. The functional level of organs must meet the following requirements:

    1. Blood routine ANC≥1.5×10 9/L; PLT≥90×10 9/L; Hb≥90 g/L;
    2. 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);
    3. Heart color Doppler ultrasound LVEF≥50%;
    4. 12-lead ECG Fridericia method corrected QT interval (QTcF) female <470 ms.
  7. Patients with known hormone receptor status.
  8. 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.
  9. During the trial period and within 6 months after the trial, female subjects should take medically acceptable or reliable contraceptive measures;
  10. 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.

Exclusion Criteria:

  1. 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) ；
  2. Inflammatory breast cancer; metastatic breast cancer (stage IV)
  3. A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency and a history of organ transplantation;
  4. 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.
  5. 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.
  6. 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.).
  7. Have a clear history of neurological or mental disorders, including epilepsy or dementia.
  8. Any other situation that the researcher considers inappropriate to participate in this research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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.
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.
Estimated up to 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sichuan Provincial People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jun Luo, Master, Sichuan Provincial People's Hospital
  • Study Director: Jie Chen, Master, Sichuan Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MIES-BCNAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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