Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Lymphatic Metastasis

Neoplastic Processes

Breast Diseases

Skin Diseases

Intervention: procedure: wire localization

Pathologically proven positive axillary lymph node will be clip-marked before the initiation of neoadjuvant chemotherapy. After the completion of neoadjuvant chemotherapy, a wire will be placed to localize the clip-marked node before surgery. During surgery, a standard sentinel lymph node biopsy will be performed as well as the removal of the wire localized node. ALND will be performed in all participants.

wire localization

Xinguang Wang, Dr.

Zhaoqing Fan, Dr.

Tao Ouyang, Dr.

The investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in clinical stage N1 (cN1) breast cancer patients. Accuracy of sentinel lymph node biopsy (SLNB) alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. New model to predict lymph node pathological complete remission (pCR) so as to safely avoid axillary lymph node dissection in cN1 breast cancer patients is sought for.

The investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in cN1 breast cancer patients. In brief, pathologically proven positive axillary lymph node will be clip-marked before the initiation of neoadjuvant chemotherapy (NACT) and continuously monitored through out the course of chemotherapy with ultrasound. After the completion of neoadjuvant chemotherapy, a wire will be placed to localize the clip-marked node before surgery. During surgery, a standard sentinel lymph node biopsy will be performed as well as the removal of the wire localized node. Axillary lymph node dissection (ALND) will be performed in all participants. Accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. Axillary ultrasound and CT scan will be performed before and after neoadjuvant chemotherapy for all patients enrolled. By assessing clinical-pathological and imaging data acquired from this trial, the investigator look forward to developing a model to accurately predict lymph node pCR (AUC \>0.85) so as to safely avoid axillary lymph node dissection in cN1 breast cancer patients.

To Accurately Assess Lymph Node Response to NACT by Wire Localization of Clip-marked Lymph Nodes

To Accurately Assess Lymph Node Response to Neoadjuvant Chemotherapy by Wire Localization of Clip-marked Axillary Lymph Nodes in Breast Cancer Patients

Sensitivity, specificity, false negative rate and negative predictive value will be calculated.

Using clinical pathological and image data collected, generate a model to predict lymph node pCR in cN1 patients.

Peking University

director of the department

Part A of this project is for physician training to master the technique of RFID placement and retrieval. On the day of surgery prior to going to the operating room, all participants will have the RFID placed first to allow radiologists to become familiar with placement of the RFID localizer. Participants will then immediately undergo wire localization. Either ultrasound or mammogram guidance will be used for the localization at the discretion of the performing radiologist. Surgeons will use a reader to locate the RFID chip during surgery. The wire will be present in the event the area of concern cannot be adequately located with the reader.

Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care.

The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.

RFID Localization

Wire Localization

Both RFID and the standard of care wire localization will be performed for physician training.

RFID and Wire Localization

Megha Garg, MD

The purpose of the project is to compare Radiofrequency identification device (RFID) localization technique with the current clinical standard wire localization technique. The Investigator's hypotheses is that the RFID localization technique is non-inferior to wire localization for breast lesions (tumors).

The study will be conducted in two parts. The purpose of Part A is for physician training with the RFID device. Nine subjects will undergo RFID and wire localization prior to breast lesion excision. This will allow the breast radiologists and surgeons to become comfortable with RFID device placement and retrieval. Additionally, the investigators will pilot the data collection surveys and chart review methodology to be used in Part B.

The purpose of Part B is to conduct a randomized clinical trial to assess whether RFID localization is non-inferior to wire localization for breast lesions. For this part, sixty subjects will be randomized to RFID (N=30) or wire localization (N=30) at time of enrollment. Surveys will be used to gather data from participants, radiologists, surgeons, and technologists/mammography nurses. A variety of data will be collected including, but not limited to, information on tumor size, location, depth; subject demographics; adequacy of tumor margins, re-excision rates, accuracy of wire or chip placement, and surgical complications.

As part of standard of care, participants will receive: an ultrasound (US) or mammographic guided localization; excisional breast surgery; and a follow-up visit in breast surgery clinic.

As part of the research protocol, participants will receive a RFID chip for the localization procedure and complete surveys.

Part A of this project is for physician training to master the technique of RFID placement and retrieval. On the day of surgery prior to going to the operating room, all participants will have the RFID placed first to allow radiologists to become familiar with placement of the RFID localizer. Participants will then immediately undergo wire localization. Either ultrasound or mammogram guidance will be used for the localization at the discretion of the performing radiologist. Surgeons will use a reader to locate the RFID chip during surgery. The wire will be present in the event the area of concern cannot be adequately located with the reader. Participants, radiologists, surgeons, breast surgery and radiology staff will complete surveys.

Part B of this project is a prospective trial to examine safety, efficacy, operating room utilization patterns, and satisfaction with RFID versus wire localization. Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). Participants will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care. Participants, radiologists, surgeons, breast surgery and radiology staff will complete surveys.

Radiofrequency Chip for Localization of Non-Palpable Breast Lesions

Use of a Radiofrequency Chip for Localization of Non-Palpable Breast Lesions: A Comparison to Wire Localization

Whether the surgeon was able to identify and remove the tumor

Survey Question: "Compared to expected, how uncomfortable was the localization?"

Scored on a scale of 1 to 5 with the best being 5

Surveys of Radiology Nurse ease of scheduling the localization procedure.

Scored on a scale of 1 to 5 with the best being 5

Surveys of radiologist satisfaction with the localization procedure.

Scored on a scale of 1 to 5 with the best being 5

Number of participants with positive margin on pathology

Health Beacons

University of Missouri-Columbia

Associate Professor of Clinical Radiology

Part A of this project is for physician training to master the technique of RFID placement and retrieval. On the day of surgery prior to going to the operating room, all participants will have the RFID placed first to allow radiologists to become familiar with placement of the RFID localizer. Participants will then immediately undergo wire localization. Either ultrasound or mammogram guidance will be used for the localization at the discretion of the performing radiologist. Surgeons will use a reader to locate the RFID chip during surgery. The wire will be present in the event the area of concern cannot be adequately located with the reader.

RFID and Wire Localization: Both RFID and the standard of care wire localization will be performed for physician training.

Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care.

RFID Localization: The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.

Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care.

Wire Localization: The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Megha Garg MD

Number of Participants With Successful Localization

Surveys of Satisfaction: Participant

Not relevant for Part A. Since our breast surgeons were not experienced with using the RFID device, Part A consisted of performing the procedure with the RFID device prior to starting data collection for this outcome. This was done so that the surgeons would have completed their learning curve on a new device before data collection for this outcome began.

Surveys of Satisfaction

Not applicable to part A. Since our breast surgeons were not experienced with using the RFID device, Part A consisted of performing the procedure with the RFID device prior to starting data collection for this outcome. This was done so that the surgeons would have completed their learning curve on a new device before data collection for this outcome began.

Number of Participants With Tumor Incompletely Excised

Overall Study

Installation of the RFID tag device wire localization)

RFID tags

Installation of the wire localization device

Wire localization

The RFID trial focuses on breast localization in patients with non-palpable breast cancers. It aims to demonstrate the improvement in patient comfort when using the Radio Frequency Identification (RFID) tag and LOCalizer™ device compared to the gold standard device.

It is an observational, prospective, single-center, 2-arm (RFID group vs. standard gold), non-randomized and category 3 comparative study. The RFID trial focuses on breast localization in patients with non-palpable breast cancers. These patients will benefit from a mastology consultation: consent will then be acquired. The RFID tag or the gold standard localization will be put in place during this consultation (one day before surgery).

Patients will fill in their questionnaire in two steps:

* during the installation of the device (RFID tag or wire localization) to evaluate the patient's pain,
* then at the 1-month post-operative consultation to assess pain in the interval until surgery Radiologists and surgeons will fill out the questionnaire dedicated to them after each procedure.

Breast Localization: RFID Tags vs Wire Localization

RFID Trial: Localization of Non-palpable Breast Lesions Using Radiofrequency Identification Tags or Wire

The value of the satisfaction score of the patient questionnaire from 0 (worst statisfaction) to 10 (better statisfaction)

overall score values from the surgeon and radiologist questionnaires

the occurrence or not of a migration of the RFID tag, histological data, the invasion of the margins and the rate of reoperation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
To Accurately Assess Lymph Node Response to NACT by Wire Localization of Clip-marked Lymph Nodes	NCT03715686	Neoplasm, Breas... Neoadjuvant Che... Lymph Node Meta... Response	wire localizati...	18 Years - 65 Years	Peking University
Radiofrequency Chip for Localization of Non-Palpable Breast Lesions	NCT03684408	Breast Tumor	RFID Localizati... Wire Localizati... RFID and Wire L...	18 Years -	University of Missouri-Columbia
Breast Localization: RFID Tags vs Wire Localization	NCT04750889	Breast Neoplasm...	RFID tags Wire localizati...	18 Years -	Centre Jean Perrin
To Accurately Assess Lymph Node Response to NACT by Wire Localization of Clip-marked Lymph Nodes	NCT03715686	Neoplasm, Breas... Neoadjuvant Che... Lymph Node Meta... Response	wire localizati...	18 Years - 65 Years	Peking University
Breast Localization: RFID Tags vs Wire Localization	NCT04750889	Breast Neoplasm...	RFID tags Wire localizati...	18 Years -	Centre Jean Perrin

Spots Global Cancer Trial Database for wire localization