Preventing lymphedema through immediate lymphatic reconstruction during surgery
Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial
This study is testing if a new surgery technique called immediate lymphatic reconstruction can help prevent lymphedema in patients with invasive breast cancer after they have lymph nodes removed.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06989099 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older diagnosed with invasive breast cancer who are scheduled for ILR during their axillary lymphadenectomy.
Not a fit: Patients who are pregnant, breastfeeding, or have pre-existing lymphedema will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of lymphedema in breast cancer patients undergoing surgery.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in reducing lymphedema risk through surgical interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.