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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.
Must not have
Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I have breast cancer confirmed by tests and will have surgery on one breast.
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I am older than 18 years.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have brain metastases.
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
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I currently have cellulitis.
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I can't lift my arm sideways or stand without help for a few minutes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Precision and reliability
Secondary study objectives
Measurement Time

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: 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
3,015 Previous Clinical Trials
13,309,260 Total Patients Enrolled
79 Trials studying Breast Cancer
131,071 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

Breast Cancer-Related Lymphedema Measurements Clinical Trial Eligibility Overview. Trial Name: NCT03861975 — N/A
Breast Cancer Research Study Groups: Breast Cancer-Related Lymphedema Measurements
Breast Cancer Clinical Trial 2023: Breast Cancer-Related Lymphedema Measurements Highlights & Side Effects. Trial Name: NCT03861975 — N/A
Breast Cancer-Related Lymphedema Measurements 2023 Treatment Timeline for Medical Study. Trial Name: NCT03861975 — N/A
~8 spots leftby May 2025
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