Recruiting

Lymphovenous Bypass

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03941756

Conditions

Anatomic Stage III Breast Cancer AJCC v8

Breast Inflammatory Carcinoma

Locally Advanced Breast Carcinoma

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Indocyanine Green

Lymphangiography

Lymphovenous Bypass

Study Details

Brief summary:

This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes or melanoma. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. It is usually done after a diagnosis of lymphedema. In this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.

Conditions

Anatomic Stage III Breast Cancer AJCC v8

Breast Inflammatory Carcinoma

Locally Advanced Breast Carcinoma

Melanoma

Study ID

NCT03941756

Start date

Aug 14, 2018

Status verified date

May, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients greater than or equal to 18 years of age.
  • Patients willing to participate.
  • Patients able to complete informed consent.
  • Patients will be eligible for inclusion if they fall into one for two groups:

  • Patients with inflammatory breast cancer, and those with locally advanced non-inflammatory breast cancer that are undergoing ALND and are anticipated to receive radiation therapy
  • Or: Patients with a diagnosis of melanoma (including unknown primary) that will undergo ALND will also be eligible for inclusion in the study as a comparator group.

Exclusion Criteria:

  • Patients taking anticoagulants within 7 days prior to surgery.
  • Patients that are known to be pregnant at the time of surgery.
  • Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period.
  • Patients with body mass index (BMI) greater than 50.0.

Study Design

Enrollment

252 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Group I (LVB)

Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.

no intervention: Group II (no intervention)

Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.

Interventions

Indocyanine Green

Given IV

Lymphangiography

Undergo lymphangiography

Lymphovenous Bypass

Undergo LVB

Primary outcome measure

  • Volumetric diagnosis of lymphedema [ Time Frame: 18 months ]
  • Incidence of lymphedema [ Time Frame: 18 months ]

Central Contacts and Locations

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Mark Schaverien

832-499-6321sehull@mdanderson.org

Sara Hull, BSN,MHA,RN

832-499-6321sehull@mdanderson.org

Principal Investigator:

Mark Schaverien

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 26, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-26.