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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: Breast Cancer-Related Lymphedema Measurements||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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)|
|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|
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.
- 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
- 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.
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
|Contact: Alphonse G. Taghian, MDemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Alphonse G. Taghian, MD 617-724-4000 firstname.lastname@example.org|
|Principal Investigator: Alphonse G. Taghian, MD|
|Principal Investigator:||Alphonse G. Taghian, MD||Dana-Farber Cancer Institute|