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LymphaTech Scanner for Breast Cancer-Related Lymphedema

Recruiting in Palo Alto (17 mi)

Overseen byAlphonse G. Taghian, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This research will compare the absolute volumes of the upper extremity using both the LymphaTech Scanner and Perometer in a cohort of patients with a history of invasive or in-situ carcinoma of the breast.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the idea that LymphaTech Scanner for Breast Cancer-Related Lymphedema is an effective treatment?

The available research shows that the LymphaTech Scanner is a reliable tool for measuring arm volume in people with breast cancer-related lymphedema. It is a noninvasive and portable method that provides accurate limb measurements, which are crucial for early diagnosis and management of the condition. Compared to traditional methods like tape measures, the LymphaTech Scanner offers faster and more consistent results, making it a valuable tool in screening programs. This helps in preventing the progression of lymphedema and improving the quality of life for patients.¹ ² ³ ⁴ ⁵

What safety data exists for the LymphaTech Scanner for breast cancer-related lymphedema?

The LymphaTech 3D Imaging System is described as a mobile, noninvasive platform for measuring limb geometry, indicating it is likely safe for use. However, the provided research does not explicitly mention specific safety data or adverse effects related to the LymphaTech Scanner. The focus is primarily on its reliability, validity, and integration into clinical assessments for breast cancer-related lymphedema.¹ ² ⁴ ⁶ ⁷

Is the LymphaTech Scanner a promising treatment for breast cancer-related lymphedema?

Yes, the LymphaTech Scanner is a promising treatment for breast cancer-related lymphedema. It offers a reliable, noninvasive, and cost-effective way to measure arm volume, which helps in early diagnosis and management of lymphedema. This technology is portable and can be easily integrated into clinical settings, making it a valuable tool for improving the quality of life for breast cancer survivors.¹ ² ³ ⁴ ⁵

Research Team

Alphonse G. Taghian, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

I have breast cancer confirmed by tests and will have surgery on one breast.

I am older than 18 years.

See 1 more

Exclusion 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.

You have a history of primary lymphedema.

See 2 more

Treatment Details

Interventions

LymphaTech Scanner (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

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 Clinic Near You

Research Locations NearbySelect from list below to view details:

Massachusetts General Hospital Cancer CenterBoston, MA

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Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3066

Patients Recruited

13,430,000+

Heinz Family Foundation

Collaborator

Trials

Patients Recruited

310+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Arm Volume in People During and After Treatment for Breast Cancer: Reliability and Convergent Validity of the LymphaTech System.Binkley, JM., Weiler, MJ., Frank, N., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of technology to facilitate a prospective surveillance program for breast cancer-related lymphedema at the Massachusetts General Hospital.Havens, LM., Brunelle, CL., Gillespie, TC., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An infrared 3D scanning device as a novel limb volume measurement tool in breast cancer patients.White, BN., Lu, IM., Kao, LS., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Augmented Reality Tools in Breast Cancer Related Lymphedema Prognostication and Diagnosis.Invernizzi, M., Runza, L., De Sire, A., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Arm Volume Using a Tape Measure Versus a 3D Optical Scanner in Survivors with Breast Cancer-Related Lymphedema.Mastick, J., Smoot, BJ., Paul, SM., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The grading of lymphedema in oncology clinical trials.Cheville, AL., McGarvey, CL., Petrek, JA., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Low-Cost, Portable, and Mobile-Based Bioimpedance Lymphedema Diagnosis and Monitoring System (Mobilymph): A Validation Study.Syed Ibrahim, SA., Ibrahim, F., Taib, NAM., et al.[2023]