Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Lymphatic Metastasis

Prosthesis Failure

Breast Diseases

Skin Diseases

Neoplastic Processes

Postoperative Complications

The cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is a training cohort.

The cohort of Sun Yat-sen University Cancer Center is a validation cohort.

The cohort of Tungwah Hospital of Sun Yat-Sen University is a validation cohort.

The cohort of Shunde hospital of southern medical university is a validation cohort.

As this is a patient registry, there are no interventions.

No interventions

Herui Yao, PhD

Yunfang Yu, MD

Jie Ouyang, PhD

Qiugen Hu, PhD

Xiaohong Li, MD

Chuanmiao Xie, PhD

Nian Lu, MD

Haotian Lin, PhD

Wenben Chen, MD

Yufang Yu, MD

Yujie Tan, MD

Kai Chen, MD

This bi-directional, multicentre study aims to assess multiparametric MRI Radiomics-based prediction model for identifying metastasis lymph nodes and prognostic prediction in breast cancer.

Sensitivity for prediction of lymph node metastasis and survival of currently available prognostic scores in limited. This study proposes to establish a deep learning algorithms of multiparametric MRI radiomics and nomogram for identifying lymph node metastasis and prognostic prediction of breast cancer. The study will investigate the relationship between the radiomics and the tumor microenvironment. The study includes the construction of multiparametric MRI radiomics-based prediction model and the validation of the prediction model.

Deep Learning Algorithms for Prediction of Lymph Node Metastasis and Prognosis in Breast Cancer MRI Radiomics (RBC-01)

Requests for the individual data or study documents will be considered where the proposed use aligns with public good purposes, does not conflict with other requests, and the requestor is willing to sign a data access agreement. Contact is though the corresponding author.

Disease free survival (DFS), which defined as the time from the diagnosis of breast cancer to the confirmed time of metastatic disease, or death due to any other cause.

Radiomics is a tool to analyze tumor microenvironment characteristics based on breast MRI images.

The value of Radiomics of multiparametric MRI in predicting axillary lymph node metastasis.

The association between Radiomics of multiparametric MRI and overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.

Defined as time between randomization and the time of death occur specific due to breast cancer

defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred

Sun Yat-sen University

Tungwah Hospital of Sun Yat-Sen University

Southern Medical University, China

Zhongshan Ophthalmic Center, Sun Yat-sen University

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Principal Investigator

Cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is the training cohort.

Cohort of Sun Yat-sen University Cancer Center is validation cohort 1.

Cohort of Tungwah Hospital of Sun Yat-Sen University is validation cohort 2.

Herui Yao, Ph. D

Chenchen Li, MD

This study is aimed to illustrate whether Radiomics combining multiparametric MRI before and after neoadjuvant chemotherapy (NACT) with clinical data is a good way to predict axillary lymph node metastasis and prognosis in invasive-breast-cancer.

This study proposes to build a clinical predictive model to predict axillary lymph node metastasis and prognosis in invasive-breast-cancer patients who received neoadjuvant chemotherapy before surgery. The model is built based on breast MRI signatures extracted and analyzed via deep machine-learning algorithm methods. Invasive breast cancer patients undergo multiparametric MRI at baseline, then undergo multiparametric MRI after received neoadjuvant chemotherapy for at least 4 cycles as planned. After the surgery, responses to neoadjuvant chemotherapy are determined according to the histopathologically examination of the surgically resected specimens. After completion of treatment procedure, patients are followed up for 5 years.

MRI Radiomics Assessing Neoadjuvant Chemotherapy in Breast Cancer to Predict Lymph Node Metastasis and Prognosis(RBC-02)

Novel Radiomics Signature on MRI Before and After Neoadjuvant Chemotherapy in Breast Cancer to Predict Axillary Lymph Node Metastasis and Prognosis (RBC-02)

The association between Radiomics of multiparametric MRI and disease free survival (DFS), which defined as the time from the diagnosis of breast cancer to the confirmed time of metastatic disease, or death due to any other cause.

The value of Radiomics of breast MRI in predicting responses to neoadjuvant chemotherapy, including reaching pCR and not reaching pCR.

The value of Radiomics of breast MRI in predicting pathological axillary lymph node status is defined as axillary lymph node metastasis exists or not.

Defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred

Principal Investigation

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

Patients in whom the magnetic marker Magseed is used will be enrolled in this study arm and will undergo targeted axillary dissection.

Patients in whom the iodine seed 125I marker is used will be enrolled in this study arm and will undergo targeted axillary dissection.

Patients in whom the carbon suspension marker is used will be enrolled in this study arm and will undergo targeted axillary dissection.

The surgical treatment procedure of targeted axillary dissection performed in patients in whom the pathological lymph nodes have been marked using the examined and compared markers (magnetic marker Magseed, iodine seed 125I, carbon suspension)

Targeted axillary dissection

Jan Žatecký, MD

A multicentre prospective comparative study, comparing the use of various markers (magnetic marker Magseed, iodine seed 125I, carbon suspension) for marking a pathological lymph node in patients with breast carcinoma prior to neoadjuvant therapy and subsequent surgical treatment consisting of targeted axillary dissection.

There are two basic aims of the study

1. Prospective comparison of the reliability and accuracy of individual markers used for marking of a pathological axillary lymph node with subsequent targeted axillary dissection.
2. Comparison of the number of complications during localizing and detection of individual markers and postoperative complications.

In individual collaborating centers, these markers are commonly used in clinical practice for marking of a pathological lymph node in patients with breast carcinoma. The usual standard of practice and treatment will not be changed in any way; the patients will only be prospectively followed. The study will bring an answer to the question of which marker is the best for marking lymph nodes.

Apart from the basic demographic and other data (patient age, side of the body, size and characteristics of the tumor (typing, grading, staging), type and time of surgery, the incidence of complications during implantation or detection of the marker, number of lymph nodes, complications after surgery, and the final histological findings, also the following outcome measures will be observed:

* depth of marker implantation (measured in mm)
* marker migration (measured in mm)
* success-rate of resection of the marked lymph node - assessment, whether the lymph node was removed (yes/no) using the respective marker, expressed in percent of successful removal for the respective marker
* time from localizing the pathological lymph node using the marker to surgery (measured n days)

Ideal Marker for Targeted Axillary Dissection

Individual participant data may be made available to other researchers upon request.

The depth of marker implantation will be assessed and measured in millimetres

Marker migration will be assessed and measured in millimetres

Assessment, whether the lymph node was removed (yes/no) using the respective marker, expressed in percent of successful removal for the respective marker.

The time from localizing the pathological lymph node using the marker to surgery will be analysed and measured in days

Silesian Hospital in Opava

Masaryk Memorial Cancer Institute

EUC Clinic in Zlín

Institute for the Care of Mother and Child, Prague, Czech Republic

University of Ostrava

University Hospital Ostrava

During standard of care (SoC) surgery to remove breast cancer, study participants will undergo a sampling of lymph nodes in the axilla first and then complete removal of axillary lymph nodes under the arm.

A surgical procedure that opens the armpit (axilla) to identify, examine, or remove lymph nodes. Axillary dissection will be performed during SoC breast cancer surgery.

Axillary Dissection

Jornan Rodriguez Leyva

Susan Kesmodel, MD

The purpose of this research is to evaluate how to manage the axillary lymph nodes in patients with breast cancer. The investigators will determine if a sampling of the lymph nodes under the arm will give the information necessary to determine if fewer lymph nodes can be removed.

Prospective Evaluation of Targeted Axillary Dissection (TAD)

TAD: Prospective Evaluation of Targeted Axillary Dissection After Neoadjuvant Systemic Therapy in Patients With Breast Cancer With Advanced Nodal Disease at Diagnosis

The false negative rate of targeted axillary dissection after neoadjuvant systemic therapy (NST) in study participants. A false negative event will be defined as a case where the specific node (either the clipped node or the sentinel lymph node, depending on the analysis) does not show metastasis even though residual disease is identified in the other axillary nodes. The false negative rate will be computed as the number of false negative events divided by the total number of pathologically node-positive patients.

The sentinel lymph node identification rate is the number of study participants with at least one sentinel lymph node divided by total number of study participants.

The clipped lymph node identification rate is the number of study participants with at least one clipped lymph node removed divided by the total number of study participants with clipped lymph nodes.

The accuracy rate of imaging studies in determining response in the breast and axilla will be calculated as the sum of true responders on imaging and true non-responders on imaging divided by total number of study participants.

The number of participants with pCR will be reported. The percentage of patients with pCR will be calculated as the number of patients with a pCR divided by the total number of study participants. PCR is defined as the lack of all signs of cancer in tissue samples removed during surgery.

Number of participants experiencing treatment-emergent adverse events (AEs). AEs will be assessed by and assigned severity and treatment attribution by the treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.

University of Miami

Associate Professor of Clinical

These patients have already undergone neoadjuvant chemotherapy for locally advanced breast cancer with metastasis to the axillary lymph nodes. During standard of care needle-directed I-125 seed localization, the research marker will also be deployed through the same needle. Ultrasound detection of the marker will be compared to conventional biopsy markers and the I-25 seed.

The research marker is a cylindrical-shaped marker made of an FDA-approved material that can be seen by ultrasound.

Research Marker

Christine Lee, MD, PhD

Researchers are trying to determine if the Mayo marker is easily seen with ultrasound making it easier, faster, and more accurate for preoperative localization of the biopsied positive lymph node.

Nonrandomized clinical trial to evaluate the Mayo-designed marker for ultrasound conspicuity at the time of preoperative ultrasound-guided localization.

Study participants are breast cancer patients with pathology-proven metastatic axillary lymph nodes. Per standard of care, a biopsy marker will have already been associated with the positive lymph node. 10 such patients scheduled for surgery at Mayo Clinic Rochester, MN with Dr. James Jakub will be enrolled. Preoperative radioactive seed localization will proceed as usual, but the marker will be additionally loaded with the seed into the needle using standard protocol. Before surgery, ultrasound will be performed to evaluate the marker.

Mayo Designed Soft Tissue Ultrasound-Detectable Marker

A Mayo-Designed Nonmetallic, Ultrasound-Detectable Marker for Metastatic Axillary Lymph Nodes in Breast Cancer

Evaluation of ultrasound conspicuity of marker placed at time of radioactive seed localization.

To compare conspicuity of marker with that of conventional biopsy markers and I-125 localization seeds.

Mayo Clinic

ALND is performed in patients with positive axillary lymph nodes on CT scan and on AAUS.

pALND is performed in patients with negative axillary lymph nodes on CT scan but positive on AAUS.

SLNB will be performed for those with negative axillary lymph nodes on CT scan and on AAUS.

ALND is performed in patients with positive axillary lymph nodes on CT scan and on AAUS. pALND is performed in patients with negative axillary lymph nodes on CT scan but positive on AAUS.SLNB will be performed for those with negative axillary lymph nodes on CT scan and on AAUS.

ALND Group

Jianyi Li, Dr

The early diagnosis and evaluation of breast cancer is of great significance to its treatment and prognosis. Among the multiple factors affecting the prognosis, the degree of axillary lymph node metastasis is one of the most vital factors.

Accurately understanding the status of axillary lymph nodes prior to surgery allows better prediction of staging, enables correct treatment plans, and guides the scope of node dissection during surgery. For patients with early breast cancer or clinically negative axillary lymph nodes, sentinel lymph node biopsy (SLNB) can largely avoid complications such as upper extremity lymphedema caused by axillary lymph node dissection (ALND). Thus, clinical identification of negative lymph nodes becomes more valuable. Based on clinical verification, the NCCN guidelines (edition 2019) made the following recommendation: SLNB is performed for patients with clinically negative axillary lymph nodes, and the biopsy findings determine whether ALND is included; ALND is performed for patients with clinically positive axillary nodes. Currently, imaging examinations have limitations is assessing axillary lymph nodes. Finding an accurate and non-invasive method in preoperative axillary assessment has been a project that needs to be urgently addressed. Ultrasonography has advantages in its simplicity, non-invasiveness, economy, and on radiation, however it is highly subjective, dependent upon examiner's experience and knowledge, and is difficult to detect deeper and small lesions. Molybdenum Target examination plays an important role in diagnosis of breast cancer, however it is expensive and limited in evaluating the whole axilla. PET-CT is restricted by its high cost and is not a routine examination in China.

Therefore, computed tomography (CT) scan is more advantageous in determination of lymph node metastasis. The 2014 GORO KUTOMI study suggested that lymph node morphology assessed as clear by preoperative CT was an independent predictor of sentinel lymph node metastasis. CT scan can not only evaluate the presence or absence of distant metastasis and pectoralis muscle invasion, but also provide intuitive, accurate and detailed evaluation of axillary, supraclavicular, and pectoralis major intramuscular lymph nodes. The diagnostic criteria of magnetic resonance imaging (MRI) is relatively vague; CT can also obtain imaging data of the lungs, mediastinum, whereas MRI has no such function. Based on previous studies, we will further explore and evaluate axillary node status using prone positioning CT scan and ultrasound in patients with breast cancer.

A total of 500 patients who are newly diagnosed with operable breast cancer in Liaoning Oncology Hospital are approached and recruited. Inclusion criteria: 1. preoperative chest CT and axillary Doppler ultrasound examination in the prone position; 2. perform ALND; 3. regular follow-up post surgery, short-term and long-term. Exclusion criteria: history of other benign or malignant tumors causing axillary lymphadenopathy.

Comparisons are made:

A: between suspiciously positive and suspiciously negative axillary lymph nodes B: between LNSD positive among suspiciously positive axillary lymph nodes and negative axillary lymph nodes f C: between positive and negative AAUS D: between positive and negative AAUS among negative lymph nodes detected by CT scan E: between positive and negative AAUS among lymph nodes with negative LNSD

Chi-square test and t test are used to assess statistical significance between groups.

Methods: Lymph node short diameter (LNSD) is measured using CT scan imaging (LNSD \> 1cm is considered positive), axillary lymph node status is assessed according to axillary lymph node Doppler ultrasound. ALND will be performed in patients with positive axillary lymph nodes on CT scan; PALND will be performed for those with negative axillary lymph nodes on CT scan but positive on AAUS; SLNB will be performed for those with negative axillary lymph nodes on CT scan and on AAUS.

The prognosis in each patient group is to be evaluated by short-term observational indicators (e.g. lymphedema and/or status of axillary lymphatic return), and long-term indicators (e.g. lymphedema and/or axillary lymph node recurrence). The accuracy of CT scan assessing positive lymph nodes and positive AAUS will be evaluated according to the postoperative histology results.

Prone Positioning CT Scan and Ultrasound Assessing Axillary Lymph Nodes in Patients With Breast Cancer Official Title: Evaluation of Axillary Lymph Nodes Using Prone Positioning Computed Tomography Scan and Ultrasound in Patients With Breast Cancer

Evaluation of Axillary Lymph Nodes Using Prone Positioning Computed Tomography Scan and Ultrasound in Patients With Breast Cancer

The accuracy of CT scan detecting positive axillary lymph node and positive AAUS is assessed by the postoperative histology results

The purpose of SLNB is to reduce the scope of axillary lymph node dissection, therefore reduce the occurrence of complications.

Axillary recurrence rate as a long-term observational indicator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Deep Learning Algorithms for Prediction of Lymph Node Metastasis and Prognosis in Breast Cancer MRI Radiomics (RBC-01)	NCT04003558	Breast Neoplasm... Early-stage Bre... Radiomics Axillary Lymph ... Survival, Prost...	No intervention...	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
MRI Radiomics Assessing Neoadjuvant Chemotherapy in Breast Cancer to Predict Lymph Node Metastasis and Prognosis(RBC-02)	NCT04004559	Invasive Breast... Neoadjuvant Che... Radiomics Axillary Lymph ... Prognosis	No intervention...	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Ideal Marker for Targeted Axillary Dissection	NCT04580251	Breast Cancer	Targeted axilla...	18 Years -	University Hospital Ostrava
Prospective Evaluation of Targeted Axillary Dissection (TAD)	NCT04998682	Breast Cancer	Axillary Dissec...	18 Years -	University of Miami
Deep Learning Algorithms for Prediction of Lymph Node Metastasis and Prognosis in Breast Cancer MRI Radiomics (RBC-01)	NCT04003558	Breast Neoplasm... Early-stage Bre... Radiomics Axillary Lymph ... Survival, Prost...	No intervention...	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Mayo Designed Soft Tissue Ultrasound-Detectable Marker	NCT04674852	Breast Neoplasm... Ultrasound Ther...	Research Marker	18 Years -	Mayo Clinic
Prone Positioning CT Scan and Ultrasound Assessing Axillary Lymph Nodes in Patients With Breast Cancer Official Title: Evaluation of Axillary Lymph Nodes Using Prone Positioning Computed Tomography Scan and Ultrasound in Patients With Breast Cancer	NCT05346510	Breast Cancer	ALND Group	18 Years - 70 Years	Shengjing Hospital
Prone Positioning CT Scan and Ultrasound Assessing Axillary Lymph Nodes in Patients With Breast Cancer Official Title: Evaluation of Axillary Lymph Nodes Using Prone Positioning Computed Tomography Scan and Ultrasound in Patients With Breast Cancer	NCT05346510	Breast Cancer	ALND Group	18 Years - 70 Years	Shengjing Hospital

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