Preventing lymphedema through immediate lymphatic reconstruction during surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate whether immediate lymphatic reconstruction (ILR) performed during axillary lymphadenectomy can reduce the risk of developing lymphedema in patients diagnosed with invasive breast cancer (IBC). The primary objective is to assess the freedom from lymphedema rate two years post-surgery. Secondary objectives include estimating the persistence of lymphedema at two years, identifying anatomical or functional characteristics that may increase lymphedema risk, and evaluating changes in inflammatory mediators and immune cell function related to lymphedema development.

Why it matters

Who can join: the full rules

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.

Where it's running

• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Mark Schaverien, MD — M.D. Anderson Cancer Center
• Study coordinator: Sara Hull, MHA, BA, BSN, RN, CCRP
• Email: sehull@mdanderson.org
• Phone: 713-794-1247

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.