Neoplasms

Skin and Connective Tissue Diseases

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Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Technetium Tc 99m Sulfur Colloid

Each patient will receive an injection of technetium-99m sulfur colloid directed subareolar or around the tumor. The material will be prepared as per manufacturer's specifications. The dose will be 20mBq given the same day of 80mBq given the day before. The Nuclear Medicine Department at St Paul's Hospital will perform the injection as per normal sentinel lymph node mapping protocol.

1. Inject radioactive isotope and scan for sentinel node (SLN) using gamma probe
2. Pre-incision: SLN is identified
3. Inject blue dye into patient's arm
4. Complete procedure (SLNB and/or ALND)

Isosulfan Blue (Patent Blue Dye V)

1. Inject radioactive isotope and scan for sentinel node (SLN) using gamma probe
2. Pre-incision: SLN is not identified (No localization)
3. Inject blue dye into breast (nothing in arm)

i. No localization: Inject blue dye into arm and perform ALND ii. Localization: Complete procedure (SLNB and/or ALND)

Sam Wiseman, MD, FRCSC, FACS

Urve Kuusk, MD, FRCSC

Carolyne Dingee, MD,FRCSC

Elaine McKevitt, MD, FRCSC

The purpose of this study is to map the arm lymphatic drainage system in the axilla with blue dye and the breast drainage system with a radioactive material. By identifying the arm lymphatics they can be protected during surgery and this may decrease the occurrence of lymphedema. The information obtained in this study may provide us with better surgical techniques to identify and protect the arm lymphatic drainage system in the axilla.

This study is a non-randomized Phase II study of the Axillary Reverse Mapping (ARM) procedure for patients presenting with breast cancer requiring lymph node evaluation. The study will enroll 100 subjects, and will have two study arms: one for patients requiring only the SLNB procedure (roughly 67% of enrollees), and one for patients requiring a full ALND (roughly 33% of enrollees). For the analysis of study efficacy, each arm will be compared to its procedure-appropriate historical control for evidence of decrease in the 1-year lymphedema rate among patients undergoing SLNB or ALND.

Additional data will be collected on the treatment population's (a) variability in location of arm lymphatics, and (b) incidence of SLN crossover with arm lymphatics, along with success-rate data for identifying SLNs and arm lymphatics during SLNB and/or ALND. This additional data will add to our level of knowledge and experience regarding lymph node surgery.

Breast Lymph Node Mapping

Axillary Reverse Mapping in Breast Cancer

University of British Columbia

The included patients will accept essential tests and CEUS before and after neoadjuvant chemotherapy to evaluate axillary lymph nodes status. When patients finish neoadjuvant therapy, SLNB with or without axillary lymph node dissection will be performed using CEUS lymphatic mapping to mark SLN on the skin combined with blue dye.

CEUS is performed before neoadjuvant treatment and surgery to evaluate the status of axillary lymph node and locate the sentinel lymph node.

CEUS

Before operation, blue dye is injected for sentinel lymph node mapping.

blue dye

Ying Lin

Zhen Shan

False negative rate (FNR) in patients who has accepted neoadjuvant therapy is high. Blue dye and radioisotope as dual-tracer can decrease FNR. Several large clinical trials showed that using dual trace with blue dye and radioisotope can reduce the FNR to less than 10%. But radioisotope is still not approved in China and can cause radiocontamination. A novel dual-tracer which can decrease the FNR in patients after neoadjuvant therapy is urged to be explored. Contrast enhanced ultrasonography (CEUS) can make the lymphatic drainage path and sentinel lymph nodes visible. Retrospective studies found that CEUS can locate SLN precisely. So this clinical trial aim to evaluate FNR, detective rate and numbers of SLN by using CEUS combined with blue dye as dual-tracer in sentinel lymph node biopsy in breast cancer patients after neoadjuvant therapy and the accuracy of CEUS for the diagnosis of lymph node metastasis before and after neoadjuvant therapy.

Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy

A Prospective Multi-center Study: Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy After Neoadjuvant Therapy in Breast Cancer

The false negative rate (FNR) of sentinel lymph node biopsy using dual-tracer with CEUS and blue dye after neoadjuvant chemotherapy in invasive breast cancer patients.

The FNR is calculated as the number of false negative cases divided by the number of false negative plus true positive cases and then multiplied by 100%.

The detective rate of SLNB after neoadjuvant therapy when using blue dye and CEUS lymphatic mapping as dual tracer.

The detective rate is calculated as the number of patients in whom SLN can be detected during SLNB divided by the number of patients with the treatment of SLNB and then multiplied by 100%.

The average numbers of sentinel lymph node is calculated as the number of all SLNs detected during SLNB divided by the number of patients received SLNB and then multiplied by 100%.

The accuracy of CEUS in evaluation of axillary lymph nodes in breast cancer patients before and after neoadjuvant therapy.

The accuracy rate is calculated as the number of true positive plus true negative cases divided by the number of patients then multiplied by 100%.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Breast Lymph Node Mapping	NCT01038908	Breast Cancer	Isosulfan Blue ... Isosulfan Blue ...	19 Years -	University of British Columbia
Breast Lymph Node Mapping	NCT01038908	Breast Cancer	Isosulfan Blue ... Isosulfan Blue ...	19 Years -	University of British Columbia
Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy	NCT04932460	Breast Neoplasm... Neoadjuvant The... Sentinel Lymph ...	CEUS blue dye	18 Years -	First Affiliated Hospital, Sun Yat-Sen University

Spots Global Cancer Trial Database for blue dye

Every month we try and update this database with for blue dye cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for blue dye

Every month we try and update this database with for blue dye cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for blue dye cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.