Lymphedema
Conditions
Brief summary
To learn if reconstruction of the lymphatic system at the time of axillary lymphadenectomy can reduce the risk of developing lymphedema.
Detailed description
Primary Objectives \- To determine the freedom from lymphedema (FFL) rate at 2 years postoperatively in participants with a diagnosis of IBC undergoing ILR at the time of ALND. Secondary Objectives * Estimate the proportion of participants who have lymphedema that persists at 2 years after ILR surgeries. * Determine baseline lymphatic vessel anatomical or functional characteristics associated with increased risk of lymphedema following ILR. * Evaluate changes in systemic inflammatory mediators and systemic immune cell function affiliated with lymphedema development.
Interventions
PROCEDUREImmediate Lymphatic Reconstruction (ILR)/
Given by Procedure
PROCEDUREProphylactic Lymphovenous Bypass (pLVB)
Given by Procedure
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from lymphedema (FFL) | 2 years |
Countries
United States
Contacts
CONTACTSara Hull, MHA, BA, BSN, RN, CCRP
PRINCIPAL_INVESTIGATORMark Schaverien, MD
M.D. Anderson Cancer Center
Outcome results
None listed