Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.

Description

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

Conditions

Lymphedema

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Study Overview

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Study Details

Study overview

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

Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial

Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.

Condition
Lymphedema
Intervention / Treatment

-

Contacts and Locations

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Mark Schaverien, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2029-08-01