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

NCT03990610 | Active Not Recruiting

• 2 other identifiers: 2018-0528NCI-2019-03182
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• Incidence rate of lymphedema development

  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

  Will be estimated by the Kaplan-Meier method.

  Up to 2 years

Secondary Outcomes (2)

• Incidence rate of lymphedema development

  Up to 2 years

• Complications of prophylactic VLNT

  Within 30 days after surgery

Study Arms (1)

Treatment (vascularized lymph node transfer)

EXPERIMENTAL

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

Procedure: Mammoplasty; Procedure: Vascularized Lymph Node Transfer

Interventions

Mammoplasty PROCEDURE

Undergo standard of care breast reconstructive surgery

Also known as: Breast Reconstruction

Treatment (vascularized lymph node transfer)

Vascularized Lymph Node Transfer PROCEDURE

Undergo vascularized lymph node transfer

Also known as: VLNT

Treatment (vascularized lymph node transfer)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammaplasty

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Edward I Chang

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 19, 2019
• Study Start: May 24, 2019
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-08

Locations

US (1)