LymphaTech Scanner for Breast Cancer-Related Lymphedema

Overseen By Alphonse G. Taghian, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Primary lymphedema, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new device, the LymphaTech Scanner, for measuring arm swelling in patients who have had breast cancer. Researchers seek to compare the scanner with another tool, the Perometer, to determine the best method for tracking lymphedema (arm swelling) in these patients. Individuals who have undergone breast cancer surgery and can move their arm comfortably might be suitable for this study. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future lymphedema care.

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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the LymphaTech Scanner is safe for measuring breast cancer-related lymphedema?

Research has shown that the LymphaTech Scanner safely measures arm size. Studies have found it to be 99% accurate compared to methods like water displacement or tape measures, providing reliable results without risk. The studies report no side effects or discomfort for users. As a measuring tool, not a medication, the scanner uses no chemicals or radiation, enhancing its safety. Overall, patients handle the LymphaTech Scanner well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LymphaTech Scanner because it offers a new, non-invasive way to measure lymphedema in breast cancer patients. Unlike traditional methods that might involve physical measurements or subjective assessments, the LymphaTech Scanner uses advanced imaging technology to precisely assess the volume of the upper extremities. This can lead to more accurate monitoring and potentially earlier intervention for patients. The technology aims to provide a quicker, more comfortable experience for patients compared to current standard practices.

What evidence suggests that the LymphaTech Scanner is effective for measuring breast cancer-related lymphedema?

Research has shown that the LymphaTech Scanner, used by participants in this trial, can accurately measure limb size, which is crucial for monitoring lymphedema (swelling from lymph fluid buildup). Studies indicate that this scanner employs infrared 3D technology to provide precise measurements, with only a small difference of 1.86% from physical measurements. This technology aims to enhance the tracking and management of swelling, which is vital for individuals with breast cancer-related lymphedema. Initial findings suggest that the LymphaTech Scanner is as reliable as the Perometer, a tool commonly used for this purpose. This evidence supports the potential of the LymphaTech Scanner as an effective tool for monitoring and managing lymphedema. ^{3 5 6 7 8}

Who Is on the Research Team?

Alphonse G. Taghian, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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.

I am older than 18 years.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Measurement

Participants undergo upper extremity volume measurements using the LymphaTech Scanner and the Perometer

3 years

Follow-up

Participants are monitored for precision and reliability of the measurement tools

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LymphaTech Scanner

Trial Overview

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.

How Is the Trial Designed?

Group I: Breast Cancer-Related Lymphedema Measurements Experimental Treatment 1 Intervention

Absolute volume of the upper extremities will be assessed using the LymphaTech Scanner and the Perometer.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Heinz Family Foundation

Collaborator

Trials

3

Recruited

310+

Published Research Related to This Trial

A new protocol using a 3D laser scanner and tablet computer has been developed for the early diagnosis of breast cancer-related lymphedema (BCRL) in high-risk patients, showing promise for improved assessment.

This digitally assisted method offers a precise, reproducible, and cost-effective way to diagnose BCRL, which is crucial since current guidelines for early detection are lacking.

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]

Breast cancer-related lymphedema (BCRL) affects about 20% of breast cancer patients, and early diagnosis through comprehensive screening can prevent its progression and improve quality of life.

The Massachusetts General Hospital's prospective screening program utilizes advanced technologies like perometry and bioimpedance spectroscopy, along with clinical assessments, to accurately diagnose and monitor BCRL, highlighting the importance of both objective and subjective data in patient care.

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]

In a study of 294 breast cancer survivors, the 3D whole-body surface scanner provided more accurate arm volume measurements compared to the traditional tape measure, which consistently reported smaller values.

The 3D scanning method showed significant potential for self-monitoring lymphedema, with overall agreement rates of 81.6% for a 200-mL volume difference criterion, indicating it could be a reliable tool for early detection of lymphedema in breast cancer survivors.

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]

The Mobilymph bioimpedance monitoring system was validated against the Quadscan 4000 and showed comparable results, making it a reliable tool for detecting breast cancer-related lymphedema (BCRL) in patients.

With 145 participants (100 with BCRL), Mobilymph demonstrated significant differences in interarm bioimpedance ratios, allowing for early diagnosis and continuous monitoring of lymphedema, which is crucial for effective management.

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]

The LymphaTech 3D Imaging System demonstrated excellent reliability and validity for measuring arm volume in women with breast cancer-related lymphedema, with intraclass correlation coefficients (ICCs) of ≥0.99, indicating high consistency in measurements.

This noninvasive and portable technology can effectively support the surveillance and management of lymphedema, making it a valuable tool in clinical and home settings.

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]

The study demonstrated that an infrared 3D scanning device (ISD) can reliably measure limb volume changes in breast cancer patients, showing a strong correlation with traditional tape measurements (R2 = 0.8518).

The ISD was effective in detecting volume changes in both unaffected and affected arms post-surgery, suggesting its potential for early identification of lymphedema risk in breast cancer survivors.

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]

The Lymphedema Working Group revised the Common Toxicity Criteria to create CTC v3.0, which includes separate criteria for volumetric increase, dermal changes, and subcutaneous fibrosis, addressing limitations of previous scales that relied solely on volume measurements.

CTC v3.0 aims to improve the assessment of lymphedema in oncology clinical trials by providing more detailed criteria, as existing scales were found inadequate for accurately grading the severity of lymphedema, particularly in cases of bilateral limb and nonlimb edema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12524797/

Preliminary Efficacy/Feasibility Study of a Breast Cancer ...

Although LymphaTech measurements are simultaneously documented and linked to the survey data for a specific encounter, endorsing swelling and ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03861975

Exploring the Efficacy and Feasibility of the LymphaTech ...

Our trial seeks to assess the efficacy of the LymphaTech Scanner as compared to the Perometer, which is currently used to screen for breast cancer-related ...

3.

wjso.biomedcentral.com

wjso.biomedcentral.com/articles/10.1186/s12957-020-02043-y

An infrared 3D scanning device as a novel limb volume ...

Technology utilizing infrared 3D scanners can reliably measure limb volume pre- and post-treatment similarly to tape measure in a small sample of patients.

4.

meeting.aaps1921.org

meeting.aaps1921.org/program/2024/P50.cgi

Utilization of an Infrared 3D Scanner for the Assessment of ...

Conclusions While the 3D scanner measurements were statistically different from the physical measurements, a 1.86% difference between is not clinically ...

5.

klosetraining.com

klosetraining.com/wp-content/uploads/2020/11/LymphaTech-Physical-Therapy_2020.pdf

Original Research

The LymphaTech 3D Imaging System (LymphaTech,. Atlanta, GA, USA) was developed to improve the measurement challenges associated with lymphedema. The goal is to ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7592580/

An infrared 3D scanning device as a novel limb volume ...

Published data reports a wide range of 2–65% of breast cancer survivors suffering from lymphedema [3–6]. Lymphedema is a risk factor for other adverse events, ...

7.

lymphatechnology.com

lymphatechnology.com/

LymphaTech | Accurate, reliable 3D measurement for ...

LymphaTech's system is 99% accurate compared to water displacement for volume and tape measure for circumference, validated through external clinical research.

8.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/tbj.14221

Use of a portable infrared 3D scanning device measuring ...

Assessing arm volume in people during and after treatment for breast cancer: reliability and convergent validity of the lymphatech system. Phys ...