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| Name | Class |
|---|---|
| Heinz Family Foundation | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer-Related Lymphedema Measurements | Experimental | Absolute volume of the upper extremities will be assessed using the LymphaTech Scanner and the Perometer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast Cancer-Related Lymphedema Measurements | Other | All patients will receive bilateral arm measurements using the LymphaTech Scanner and the Perometer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement Time | To evaluate amount of time it takes to conduct bilateral arm measurements with both the LymphaTech Scanner and Perometer. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alphonse G. Taghian, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
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
Data can be shared no earlier than 1 year following the date of publication
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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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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This is an interventional, non-therapeutic screening trial comparing two measurement devices cross-sectionally.
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| D017437 |
| Skin and Connective Tissue Diseases |