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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
Patients who have undergone treatment (mastectomy, axillary lymph node dissection [ALND], radiation and chemotherapy) for breast cancer and are seeking breast reconstruction
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have completed treatment for breast cancer and am seeking breast reconstruction.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to lymphedema development
Secondary outcome measures
Complications of prophylactic VLNT
Incidence rate of lymphedema development
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.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,244 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,608 Previous Clinical Trials
40,915,308 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant capacity of this research endeavor?
"Correct. Analysis of the clinicaltrials.gov page indicates that this study, which was initially advertised on May 24th 2019, is currently enrolling participants. 25 individuals are being sought at a single medical centre."
Answered by AI
Are there any current vacancies for individuals to take part in this research?
"As indicated on clinicaltrials.gov, this experiment is presently engaging subjects and was originally uploaded on May 24th 2019. It has been revised as recently as May 4th 2022."
Answered by AI
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