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Procedure
Surgical Procedure for Breast Cancer
N/A
Waitlist Available
Led By Edward I Chang
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing how well an investigational surgery called vascularized lymph node transfer works in lowering the risk of arm swelling (lymphedema) in patients with breast cancer who are undergoing breast reconstruction.
Who is the study for?
This trial is for breast cancer patients who've had a mastectomy, lymph node removal, radiation, and chemotherapy and are now planning breast reconstruction. It's not for those pregnant or allergic to specific dyes used during surgery.
What is being tested?
The study tests a new surgical method called vascularized lymph node transfer alongside breast reconstruction to see if it can reduce the risk of developing arm swelling (lymphedema) after surgery.
What are the potential side effects?
Potential side effects may include complications from surgery such as infection, poor wound healing, fluid buildup in the affected limb or area where nodes were taken from, and possibly limited range of motion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to lymphedema development
Secondary study objectives
Complications of prophylactic VLNT
Incidence rate of lymphedema development
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (vascularized lymph node transfer)Experimental Treatment2 Interventions
Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vascularized Lymph Node Transfer
2011
N/A
~180
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,802 Total Patients Enrolled
147 Trials studying Breast Cancer
63,203 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,212 Total Patients Enrolled
943 Trials studying Breast Cancer
1,443,257 Patients Enrolled for Breast Cancer
Edward I ChangPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have completed treatment for breast cancer and am seeking breast reconstruction.You are allergic to indocyanine green (ICG) or isosulfan blue (Lymphazurin).
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (vascularized lymph node transfer)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.