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Exploring the Efficacy and Feasibility of the LymphaTech Scanner for Breast Cancer-Related Lymphedema Screening

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breast Cancer-Related Lymphedema Measurements
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • Ability to understand and the willingness to verbally consent to the trial

Exclusion Criteria:

  • History of primary lymphedema.
  • Any patient with a current case of cellulitis.
  • 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.
  • Participants unable to abduct upper-extremity perpendicular to body or to stand comfortably without aid for several minutes, both of which are necessary to perform a LymphaTech Scan

Sites / Locations

  • Massachusetts General Hospital Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Breast Cancer-Related Lymphedema Measurements

Arm Description

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

Outcomes

Primary Outcome Measures

Precision and reliability
To determine whether the LymphaTech scanner is a precise and reliable tool for measuring upper extremity volume changes in patients treated for breast

Secondary Outcome Measures

Measurement Time
To evaluate amount of time it takes to conduct bilateral arm measurements with both the LymphaTech Scanner and Perometer.

Full Information

First Posted
March 1, 2019
Last Updated
April 17, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Heinz Family Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03861975
Brief Title
Exploring the Efficacy and Feasibility of the LymphaTech Scanner for Breast Cancer-Related Lymphedema Screening
Official Title
Exploring the Efficacy and Feasibility of the LymphaTech Scanner for Breast Cancer-Related Lymphedema Screening
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2019 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Heinz Family Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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 lymphedema. The focus of the study is to compare the absolute volumes of the upper-extremity as measured by each device and to compare the time it takes to measure both arms of a patient using each device to assess clinical feasibility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is an interventional, non-therapeutic screening trial comparing two measurement devices cross-sectionally.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breast Cancer-Related Lymphedema Measurements
Arm Type
Experimental
Arm Description
Absolute volume of the upper extremities will be assessed using the LymphaTech Scanner and the Perometer.
Intervention Type
Other
Intervention Name(s)
Breast Cancer-Related Lymphedema Measurements
Intervention Description
All patients will receive bilateral arm measurements using the LymphaTech Scanner and the Perometer.
Primary Outcome Measure Information:
Title
Precision and reliability
Description
To determine whether the LymphaTech scanner is a precise and reliable tool for measuring upper extremity volume changes in patients treated for breast
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Measurement Time
Description
To evaluate amount of time it takes to conduct bilateral arm measurements with both the LymphaTech Scanner and Perometer.
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Ability to understand and the willingness to verbally consent to the trial Exclusion Criteria: History of primary lymphedema. Any patient with a current case of cellulitis. 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. Participants unable to abduct upper-extremity perpendicular to body or to stand comfortably without aid for several minutes, both of which are necessary to perform a LymphaTech Scan
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alphonse G. Taghian, MD
Phone
617-724-4000
Email
ataghian@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alphonse G. Taghian, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alphonse G. Taghian, MD
Phone
617-724-4000
Email
ataghian@partners.org
First Name & Middle Initial & Last Name & Degree
Alphonse G. Taghian, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

Learn more about this trial

Exploring the Efficacy and Feasibility of the LymphaTech Scanner for Breast Cancer-Related Lymphedema Screening

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