NCT06989099 Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.
| NCT ID | NCT06989099 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Lymphedema |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-09-24 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2024-09-24 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To learn if reconstruction of the lymphatic system at the time of axillary lymphadenectomy can reduce the risk of developing lymphedema.
Eligibility 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.
Contact & Investigator
Mark Schaverien, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06989099 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphedema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06989099 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06989099 currently recruiting?
Yes, NCT06989099 is actively recruiting participants. Contact the research team at sehull@mdanderson.org for enrollment information.
Where is the NCT06989099 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06989099 clinical trial?
NCT06989099 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Mark Schaverien, MD at M.D. Anderson Cancer Center. The trial plans to enroll 50 participants.