Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Carcinoma

Breast Neoplasms

Carcinoma, Ductal

Lymphedema

Carcinoma in Situ

Carcinoma, Intraductal, Noninfiltrating

Breast Carcinoma In Situ

Breast Diseases

Skin Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Axillary reverse mapping and sentinel lymph node biopsy (ARM/SLNB) or Axillary reverse mapping and axillary lymph node dissection (ARM/ALND)

The control group will have standard sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) without identifying or sparing upper-limb lymphatics and nodes (blue dye is not injected).

ARM/SLNB: patient will be injected with technetium-99 radiolabelled colloid (Tc-99) into the subareolar area of breast, then 1-2 mls of blue dye (patent blue dye) injected subcutaneously into the medial ipsilateral arm, just proximal to the medial epicondyle of the elbow, at the start of the surgical procedure. the SLN(s) will be identified ("hot node") and removed, and any blue lymph nodes and lymphatics will be preserved intact, and only removed or disrupted if there is 'crossover" (i.e. the blue node is also the SLN) or if clinically suspicious for metastatic disease. ARM/ALND: 1-2 mls of blue dye will be injected subcutaneously into the medial ipsilateral arm at the start of the surgical procedure. Surgeons will perform a standard level I and II axillary dissection and any blue lymph nodes or lymphatics will be preserved intact, and only removed or disrupted if blue nodes are suspicious for metastatic disease.

axillary reverse mapping (ARM)

The control group will have standard SLNB or ALND surgery without identifying or sparing upper-limb lymphatics and nodes (blue dye is not injected).

Standard axillary surgery (SLNB or ALND)

Peter Lovrics, MD

Nicole Hodgson, MD, MSc

The purpose of this pilot study is to compare a new surgical technique (axillary reverse mapping) to standard axillary surgery in patients diagnosed with invasive or in situ breast cancer.

Lymphedema is a major chronic morbidity that occurs in patients undergoing treatment for breast cancer (BC). Surgery for BC includes axillary surgery with either sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). Lymphedema occurs due to removal or disruption of lymphatic drainage of the arm that overlaps with drainage of the breast. The risk of lymphedema increases significantly with adjuvant radiation. Axillary reverse mapping (ARM) is a technique where blue dye is injected into the upper arm at surgery, allowing direct visualization of arm lymphatics and nodes during either SLNB or ALND. This allows preservation of arm lymphatics unless there is suspicion of metastatic disease in ARM lymphatics or if the ARM node is/are also the sentinel lymph node. Studies to date have largely been observational cohort studies, and mainly with low risk patients undergoing SLNB only. There is only one published randomized controlled trial, and this included only patients undergoing modified radical mastectomy.Our proposal is a prospective randomized pilot study. The study population includes patients undergoing axillary surgery (SLNB with mastectomy or ALND with either BCS or mastectomy or completion ALND after positive SLNB). The intervention group will undergo ARM; the control will undergo standard surgical treatment. Both groups will undergo standardized baseline and postoperative arm measurements and patients will complete symptom and quality of life questionnaires. The purpose is to determine the feasibility of the ARM technique, its accuracy in identifying and sparing arm lymphatics, and its ability to reduce the risk of lymphedema.

Axillary Reverse Mapping (ARM) Technique

A Pilot Randomized Controlled Trial Comparing the Axillary Reverse Mapping (ARM) Technique to Standard Axillary Surgery in Breast Cancer Patients.

Arm circumference measurements of both arms. An arm volume difference of \> 10% will be considered clinically significant lymphedema

infection, hematoma, problems with wound healing

Hamilton Health Sciences Corporation

St. Joseph's Healthcare Hamilton

McMaster University

Principal Investigator

Wide excision of DCIS; no radiotherapy (RT).

Wide excision of DCIS and a minimum of 1cm histologically negative margin of breast tissue

Observation

Julia Wong, MD

The purpose of this study is to determine if wide excision (surgical removal) alone is adequate treatment for small, grade 1 or 2 ductal carcinoma in situ (DCIS) of the breast.

* Patients with DCIS are usually treated with the combination of breast-conserving surgery and radiation therapy or breast-conserving surgery alone. The purpose of this study is to evaluate whether localized low- or intermediate-grade DCIS, diagnosed with modern mammography and careful pathologic evaluation, could be treated with wide excision alone (omission of radiation therapy) and result in acceptably low local recurrence rates.
* Follow-up consists of physical examinations at least every 6 months by the surgeon or radiation oncologist. Mammograms of the affected breast will be obtained every 6 months for 5 years and then annually. Mammograms of the unaffected breast will be performed annually.

Wide Excision Alone as Treatment for Ductal Carcinoma in Situ of The Breast

Wide Excision Alone for DCIS-Grades 1 and 2

Using information gathered from follow-up physical examinations and mammography to check for recurrence (DCIS or invasive carcinoma in the breast), DCIS patients treated with wide excision alone will be evaluated.

Using information gathered from follow-up physical examinations and mammography, the exploration of breast recurrences between grade 2 DCIS and grade 1 DCIS patients will be evaluated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Axillary Reverse Mapping (ARM) Technique	NCT03109522	Invasive Breast... Ductal Carcinom...	axillary revers... Standard axilla...	18 Years -	McMaster University
Wide Excision Alone as Treatment for Ductal Carcinoma in Situ of The Breast	NCT00165256	Ductal Carcinom...	Observation	18 Years -	Dana-Farber Cancer Institute
Axillary Reverse Mapping (ARM) Technique	NCT03109522	Invasive Breast... Ductal Carcinom...	axillary revers... Standard axilla...	18 Years -	McMaster University
Axillary Reverse Mapping (ARM) Technique	NCT03109522	Invasive Breast... Ductal Carcinom...	axillary revers... Standard axilla...	18 Years -	McMaster University

Spots Global Cancer Trial Database for ductal carcinoma in situ of the breast