Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.
ConditionLymphedema
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To learn if reconstruction of the lymphatic system at the time of axillary lymphadenectomy can reduce the risk of developing lymphedema.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants diagnosed with IBC.
Participants who have been scheduled for ILR/pLVB by their treating physician/surgeon at the time of their axillary lymphadenectomy for breast cancer
Participants willing and able to comply with the study protocol requirements and all study-related visit requirements.
Female subjects at least 18 years old and capable of providing consent to participate.
Disqualifiers
Patients known to be pregnant or breast-feeding.
Patients with known or suspected iodine or ICG hypersensitivity.
Patients unable to remain stationary for one hour.
Active cellulitis.
Trial design
Design model
Single group
Treatments tested in this trial
Immediate Lymphatic Reconstruction (ILR)/
Procedure/SurgeryGiven by Procedure
Prophylactic Lymphovenous Bypass (pLVB)
Procedure/SurgeryGiven by Procedure
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Postoperative EvaluationsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Freedom from lymphedema (FFL)
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov