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LymphaTech Scanner for Breast Cancer-Related Lymphedema
N/A
Recruiting
Led By Alphonse G. Taghian, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have histologically or cytologically confirmed invasive or in-situ carcinoma of the breast and will undergo unilateral breast cancer surgery
Age >18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial will compare how much extra lymph fluid is in the arms of people who have had breast cancer surgery, using two different machines.
Who is the study for?
This trial is for adults over 18 with invasive or in-situ breast cancer who are scheduled for unilateral breast surgery. They must be able to stand unaided and move their arm sideways, understand the study, and verbally agree to participate. Excluded are those with primary lymphedema, current cellulitis, severe illnesses like heart failure or unstable angina, psychiatric issues affecting compliance, or brain metastases.Check my eligibility
What is being tested?
The study is testing the effectiveness of the LymphaTech Scanner compared to the Perometer for measuring upper extremity volume in patients who have had breast cancer. It aims to determine if LymphaTech can accurately screen for lymphedema after breast surgery.See study design
What are the potential side effects?
Since this trial involves non-invasive measurements rather than drug treatments, there are no direct side effects from interventions like medications. However, discomfort during measurement due to arm movement may occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have breast cancer confirmed by tests and will have surgery on one breast.
Select...
I am older than 18 years.
Select...
I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Precision and reliability
Secondary outcome measures
Measurement Time
Trial Design
1Treatment groups
Experimental Treatment
Group I: Breast Cancer-Related Lymphedema MeasurementsExperimental Treatment1 Intervention
Absolute volume of the upper extremities will be assessed using the LymphaTech Scanner and the Perometer.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,198,345 Total Patients Enrolled
80 Trials studying Breast Cancer
132,812 Patients Enrolled for Breast Cancer
Heinz Family FoundationUNKNOWN
2 Previous Clinical Trials
182 Total Patients Enrolled
2 Trials studying Breast Cancer
182 Patients Enrolled for Breast Cancer
Alphonse G. Taghian, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
142 Total Patients Enrolled
1 Trials studying Breast Cancer
142 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I do not have brain metastases.I have breast cancer confirmed by tests and will have surgery on one breast.You have a history of primary lymphedema.I currently have cellulitis.I am older than 18 years.I can't lift my arm sideways or stand without help for a few minutes.I am older than 18 years.
Research Study Groups:
This trial has the following groups:- Group 1: Breast Cancer-Related Lymphedema Measurements
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.
Are participants still being recruited for this clinical investigation?
"Yes, according to clinicaltrials.gov this experiment is actively enrolling subjects. This trial was posted on the 30th of January 2019 and its last update occurred on May 2nd 2022."
Answered by AI
Are there any limitations on the number of participants in this investigation?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial, which was first publicized on January 30th 2019, is actively recruiting participants. The study necessitates 100 patients from a single medical institution."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Massachusetts General Hospital Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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