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Procedure
Lymphovenous Bypass Procedure for Breast Cancer
N/A
Recruiting
Led By Mark Schaverien
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 18 months
Awards & highlights
Study Summary
This trial studies a procedure to reduce risk of lymphedema in breast cancer patients before surgery. It creates a path for lymphatic fluid to flow away from the arms.
Who is the study for?
This trial is for adults over 18 with inflammatory or locally advanced non-inflammatory breast cancer, planning to have underarm lymph node surgery and radiation therapy. It's not for pregnant individuals, those unable to follow up for at least 18 months, patients on anticoagulants within a week of surgery, or with a BMI over 50.Check my eligibility
What is being tested?
The study tests if the lymphovenous bypass procedure can prevent arm swelling (lymphedema) when done before underarm lymph node surgery in breast cancer patients. Lymphangiography and Indocyanine Green are used to help perform this preventive measure.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of the procedure, risk of infection from surgery, possible allergic reactions to dyes like Indocyanine Green used during imaging, and general surgical risks such as bleeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of lymphedema
Volumetric diagnosis of lymphedema
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (LVB)Experimental Treatment3 Interventions
Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.
Group II: Group II (no intervention)Active Control1 Intervention
Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lymphangiography
2018
N/A
~130
Indocyanine green
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,069 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,653 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Mark SchaverienPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have inflammatory breast cancer, or non-inflammatory breast cancer that is being treated with ALND and radiation therapy.You are 18 years old or older.You have taken blood thinners within 7 days before surgery.You have a very high body mass index (BMI).
Research Study Groups:
This trial has the following groups:- Group 1: Group I (LVB)
- Group 2: Group II (no intervention)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
How many subjects are being monitored in the current research initiative?
"At this moment in time, the trial is not recruiting new participants. Initially published on August 14th 2018 and most recently updated March 13th 2020, no additional patients are being accepted into the study. Nonetheless, if you are exploring other clinical studies there are 2363 active breast cancer trials and 28 accepting Group I (LVB) individuals."
Answered by AI
Are there currently opportunities for participants to join this clinical experiment?
"As indicated on clinicaltrials.gov, this particular trial is not actively recruiting patients at the moment. It was first posted in August 2018 and last edited in March 2020, but there are 2391 other medical studies currently seeking participants."
Answered by AI
Who else is applying?
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
trying to see if i can help provide treatment for lymphedema people.
PatientReceived no prior treatments
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