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

100 Participants Needed

Trial Summary

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 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 data supports the effectiveness of the LymphaTech Scanner treatment for breast cancer-related lymphedema?

The LymphaTech Scanner is a noninvasive tool that helps measure arm volume accurately, which is important for detecting lymphedema early in breast cancer patients. Studies show that 3D scanning technology, like the LymphaTech Scanner, can provide reliable and precise measurements, making it a useful tool for monitoring and diagnosing lymphedema. ^{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 safe for use in humans?

The LymphaTech Scanner is described as a mobile, noninvasive platform for measuring limb geometry, which suggests it is generally safe for use in humans. ^{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}

How does the LymphaTech Scanner treatment for breast cancer-related lymphedema differ from other treatments?

The LymphaTech Scanner is unique because it uses a mobile, noninvasive 3D imaging system to measure limb geometry, providing a precise and reliable way to assess lymphedema. Unlike traditional methods like tape measures or water displacement, this technology offers a faster and more accurate diagnosis, which can help in early detection and management of the condition. ^{1 2 3 4 5}

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.

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. United States 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. [2020]

2. China pubmed.ncbi.nlm.nih.gov

Use of technology to facilitate a prospective surveillance program for breast cancer-related lymphedema at the Massachusetts General Hospital. [2021]

3. England pubmed.ncbi.nlm.nih.gov

An infrared 3D scanning device as a novel limb volume measurement tool in breast cancer patients. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Integrating Augmented Reality Tools in Breast Cancer Related Lymphedema Prognostication and Diagnosis. [2020]

5. United States 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The grading of lymphedema in oncology clinical trials. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Low-Cost, Portable, and Mobile-Based Bioimpedance Lymphedema Diagnosis and Monitoring System (Mobilymph): A Validation Study. [2023]