An Investigational Surgical Procedure (Vascularized Lymph Node Transfer) in Reducing the Risk of Lymphedema in Patients With Breast Cancer Undergoing Breast Reconstruction

July 20, 2026 updated by: M.D. Anderson Cancer Center

Assessment of Outcomes Following Prophylactic Lymph Node Transfer in Patients Undergoing Autologous Breast Reconstruction

This trial studies how an investigational surgical procedure called vascularized lymph node transfer works in lowering the risk of arm swelling (lymphedema) in patients with breast cancer undergoing breast reconstruction. Patients who undergo breast reconstruction are often at high risk of developing lymphedema. Vascularized lymph node transfer involves transferring lymph nodes from an unaffected area of the body to replace those removed as part of treatment, which may lower the risk of lymphedema after breast reconstruction.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. Determine incidence of patients who develop lymphedema following autologous breast reconstruction.

SECONDARY OBJECTIVES:

I. Determine the overall complications of prophylactic vascularized lymph node transfers.

II. Compare the incidence of patients who develop lymphedema following autologous breast reconstruction among patients who had prophylactic lymph node transfer and a historical cohort who did not have prophylactic lymph node transfer.

OUTLINE:

Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.

After completion of study, patients are followed up for 3 weeks, at 3 and 6 months, and then at 1 and 2 years.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who have undergone treatment (mastectomy, axillary lymph node dissection [ALND], radiation and chemotherapy) for breast cancer and are seeking breast reconstruction

Exclusion Criteria:

  • Patients that are known to be pregnant at the time of surgery
  • Patients with a known hypersensitivity to indocyanine green (ICG) and/or isosulfan blue (Lymphazurin)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (vascularized lymph node transfer)
Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.
Procedure: Mammoplasty
Undergo standard of care breast reconstructive surgery
Other Names:
  • Breast Reconstruction
Procedure: Vascularized Lymph Node Transfer
Undergo vascularized lymph node transfer
Other Names:
  • VLNT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of lymphedema development
Time Frame: At 12 months after surgery
Summary statistics such as means, standard deviations, median and range for continuous variables, and frequencies and percentages for categorical variables will be reported. The rate of lymphedema and its 95% exact confidence interval will be estimated.
At 12 months after surgery
Time to lymphedema development
Time Frame: Up to 2 years
Will be estimated by the Kaplan-Meier method.
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of lymphedema development
Time Frame: Up to 2 years
The incidence of lymphedema between patients who undergo vascularized lymph node transfer (VLNT) and historical cohorts who do not will be compared. The inverse probability of treatment weighting using the propensity scores will be applied to estimate the effect of VLNT.
Up to 2 years
Complications of prophylactic VLNT
Time Frame: Within 30 days after surgery
Overall complications will include infections, dehiscence, hematoma, seroma and flap compromises. The 95% exact confidence interval will be estimated.
Within 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Edward I Chang, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2019

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

June 17, 2019

First Submitted That Met QC Criteria

June 17, 2019

First Posted (Actual)

June 19, 2019

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0528 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2019-03182 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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