Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection
NCT ID: NCT03927027
Last Updated: 2026-01-26
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
534 participants
INTERVENTIONAL
2019-07-29
2027-01-31
Brief Summary
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Detailed Description
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I. To determine the occurrence of post-surgery lymphedema by conical geometric measures in clinical T1-3, N0-3, M0 breast cancer patients undergoing axillary surgery and randomized to Group 1 (no axillary reverse mapping \[ARM\]) versus Group II (ARM).
SECONDARY OBJECTIVES:
I. To compare between the study groups the lymphedema symptom intensity and distress as measured by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A).
II. To evaluate the technical success of performance of ARM procedure: Identification of ARM lymphatics, and the ability to spare or reapproximate ARM lymphatics.
III. To compare the rate of regional recurrence between patients randomized to receive ARM versus no ARM.
EXPLORATORY OBJECTIVES:
I. To assess the occurrence of lymphedema as a function of radiotherapy use and targets.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive isosulfan blue subcutaneously (SC) and undergo axillary lymph node dissection (ALND).
GROUP II: Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.
After completion of study, patients are followed up for 3 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group I (ALND)
Patients receive isosulfan blue SC and undergo ALND.
Isosulfan Blue
Given SC
Axillary Lymph Node Dissection
Undergo ALND
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Group II (ARM, ALND)
Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.
Isosulfan Blue
Given SC
Axillary Lymph Node Dissection
Undergo ALND
Mapping
Undergo ARM
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Isosulfan Blue
Given SC
Axillary Lymph Node Dissection
Undergo ALND
Mapping
Undergo ARM
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinically node negative patients undergoing mastectomy and sentinel lymph node biopsy (SLNB) with possible axillary lymph node dissection (ALND) if SLNB is positive. If ALND is performed during a separate operation, ARM procedure must be repeated. Clinically node negative is defined by i) negative clinical exam and/or ii) negative axillary US and/or iii) negative needle biopsy of sonographically suspicious axillary nodes as applicable to each case.
* Clinically node positive patients as determined by needle biopsy and planned for ALND regardless of type of breast surgery.
* Patients will be staged according to the TNM staging system.
* Prior Treatment: No prior axillary surgery except needle biopsy or concurrent SLNB.
o Prior neoadjuvant chemotherapy is allowed but must be completed at least 2 weeks before registration.
* No prior history of ipsilateral breast cancer (invasive or ductal breast carcinoma in situ \[DCIS\]). Lobular breast carcinoma in situ (LCIS) and benign disease are allowed. (May have neoadjuvant chemotherapy which must be completed 2 weeks before registration).
* No bilateral invasive breast cancer.
* No matted nodes.
* No history of lymphedema of either arm.
* No known allergies blue dyes, including make-up containing blue dye.
* In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English.
* Female :
Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer.
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
* Creatinine: =\< 1.5 x upper limit of normal (ULN).
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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V. Suzanne Klimberg, MD, PhD
Role: STUDY_CHAIR
University of Texas
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Saint John's Cancer Institute
Santa Monica, California, United States
Shaw Cancer Center
Edwards, Colorado, United States
Beebe South Coastal Health Campus
Frankford, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Goshen Center for Cancer Care
Goshen, Indiana, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
McLaren Cancer Institute-Bay City
Bay City, Michigan, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States
Cancer Institute at Saint Francis Hospital
East Hills, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Pluta Cancer Center
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
Good Samaritan Hospital Medical Center
West Islip, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Cleveland Clinic Akron General
Akron, Ohio, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, United States
Geauga Hospital
Chardon, Ohio, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Mount Carmel East Hospital
Columbus, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, United States
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio, United States
Mount Carmel New Albany Surgical Hospital
New Albany, Ohio, United States
University Hospitals Parma Medical Center
Parma, Ohio, United States
University Hospitals Portage Medical Center
Ravenna, Ohio, United States
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, United States
University Hospitals Sharon Health Center
Wadsworth, Ohio, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States
UH Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio, United States
UHHS-Westlake Medical Center
Westlake, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Geisinger South Wilkes-Barre
Wilkes-Barre, Pennsylvania, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States
Women and Infants Hospital
Providence, Rhode Island, United States
UTMB Health Angleton Danbury Campus
Angleton, Texas, United States
MD Anderson in The Woodlands
Conroe, Texas, United States
Parkland Memorial Hospital
Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
MD Anderson West Houston
Houston, Texas, United States
MD Anderson League City
League City, Texas, United States
UTMB Cancer Center at Victory Lakes
League City, Texas, United States
MD Anderson in Sugar Land
Sugar Land, Texas, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Countries
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References
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Levy AS, Murphy AI, Ishtihar S, Peysakhovich A, Taback B, Grant RT, Ascherman JA, Feldman S, Rohde CH. Lymphatic Microsurgical Preventive Healing Approach for the Primary Prevention of Lymphedema: A 4-Year Follow-Up. Plast Reconstr Surg. 2023 Feb 1;151(2):413-420. doi: 10.1097/PRS.0000000000009857. Epub 2022 Nov 15.
Other Identifiers
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NCI-2018-02445
Identifier Type: REGISTRY
Identifier Source: secondary_id
A221702
Identifier Type: -
Identifier Source: org_study_id
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