Recruiting
Phase 2

Lymphatic Reconstruction

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06989099

Conditions

Lymphedema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Immediate Lymphatic Reconstruction (ILR)/

Prophylactic Lymphovenous Bypass (pLVB)

Study Details

Brief summary:

To learn if reconstruction of the lymphatic system at the time of axillary lymphadenectomy can reduce the risk of developing lymphedema.

Conditions

Lymphedema

Study ID

NCT06989099

Start date

Sep 24, 2024

Status verified date

Feb, 2026

Completion date

Aug 1, 2029

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Participants diagnosed with IBC.
2. Participants who have been scheduled for ILR/pLVB by their treating physician/surgeon at the time of their axillary lymphadenectomy for breast cancer
3. Participants willing and able to comply with the study protocol requirements and all study-related visit requirements.
4. Female subjects at least 18 years old and capable of providing consent to participate.
5. Females of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration and agree to use a medically accepted method of contraception for a period of one month following the study.

Exclusion Criteria:

1. Patients known to be pregnant or breast-feeding.
2. Patients with known or suspected iodine or ICG hypersensitivity.
3. Patients unable to remain stationary for one hour.
4. Active cellulitis.
5. Subjects with a preoperative clinical lymphedema diagnosis.
6. Subjects undergoing bilateral ALND.
7. Subjects requiring immediate chest wall reconstruction with a pedicled or microvascular flap, or those that have received preoperative radiation therapy.
8. Patients with BMI >45kg/m2.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Postoperative Evaluations

Participants who agree to take part in this study, clinic visit timing will be exactly the same time as would ordinarily be scheduled: before surgery, then 6, 12, 18, and 24 months after surgery. Each study visit should take about 2-3 hours.

Interventions

Immediate Lymphatic Reconstruction (ILR)/

Given by Procedure

Prophylactic Lymphovenous Bypass (pLVB)

Given by Procedure

Primary outcome measure

  • Freedom from lymphedema (FFL) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Sara Hull, MHA, BA, BSN, RN, CCRP

713-794-1247sehull@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Sara Hull, MHA, BA, BSN, RN, CCRP

713-794-1247sehull@mdanderson.org

Principal Investigator:

Mark Schaverien, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-02-19.