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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03861975
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : May 22, 2020
Sponsor:
Collaborator:
Heinz Family Foundation
Information provided by (Responsible Party):
Alphonse Taghian, MD, PhD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Breast Cancer-Related Lymphedema Measurements Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is an interventional, non-therapeutic screening trial comparing two measurement devices cross-sectionally.
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Exploring the Efficacy and Feasibility of the LymphaTech Scanner for Breast Cancer-Related Lymphedema Screening
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : January 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Breast Cancer-Related Lymphedema Measurements
Absolute volume of the upper extremities will be assessed using the LymphaTech Scanner and the Perometer.
Other: Breast Cancer-Related Lymphedema Measurements
All patients will receive bilateral arm measurements using the LymphaTech Scanner and the Perometer.




Primary Outcome Measures :
  1. Precision and reliability [ Time Frame: 3 years ]
    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 :
  1. Measurement Time [ Time Frame: 3 years ]
    To evaluate amount of time it takes to conduct bilateral arm measurements with both the LymphaTech Scanner and Perometer.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861975


Contacts
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Contact: Alphonse G. Taghian, MD 617-724-4000 ataghian@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alphonse G. Taghian, MD    617-724-4000    ataghian@partners.org   
Principal Investigator: Alphonse G. Taghian, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Heinz Family Foundation
Investigators
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Principal Investigator: Alphonse G. Taghian, MD Dana-Farber Cancer Institute
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Responsible Party: Alphonse Taghian, MD, PhD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03861975    
Other Study ID Numbers: 18-181
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alphonse Taghian, MD, PhD, Massachusetts General Hospital:
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Postoperative Complications
Pathologic Processes