Ignite Creation Date:
2025-12-18 @ 9:53 AM
Ignite Modification Date:
2025-12-18 @ 9:53 AM
Study NCT ID:
NCT02724514
Status:
None
Last Update Posted:
2019-11-27 00:00:00
First Post:
2015-03-02 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-Parametric Assessment of Breast Lymphedema
Sponsor:
None
Organization:
Study Overview
Official Title:
Multi-Parametric Assessment of Breast Lymphedema
Status:
None
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breast lymphedema (swelling due to fluid) is a common complication of breast cancer therapy. Limited research has been conducted on the frequency of breast lymphedema with most studies reporting the incidence as ranging from 33 to 48%. Women with breast lymphedema describe breast fullness, heaviness and pain associated with breast swelling and changes that impacts how the breast looks (cosmesis) and also impacts their quality of life.
At present, no objective and standardized tools exist to evaluate breast lymphedema and correlate it with tissue fluid and fibrosis, and their relationships to local symptoms, cosmesis and quality of life.
The goal of the study is to assess and compare photographic, ultrasound and the breast composition in newly diagnosed breast lymphedema, and to assess the use of breast massage to manage breast lymphedema. Developing non-invasive image-based methods may enable researchers to map the extent of lymphedema, monitor its progression and evaluate therapies. This may allow for improved quantitate measures to be undertaken to better assess future strategies intended to prevent or improve the management of this treatment complication.
Patients participating in this study will have ultrasound scans before and after the massage. They will also be asked to complete a questionnaire.
At present, no objective and standardized tools exist to evaluate breast lymphedema and correlate it with tissue fluid and fibrosis, and their relationships to local symptoms, cosmesis and quality of life.
The goal of the study is to assess and compare photographic, ultrasound and the breast composition in newly diagnosed breast lymphedema, and to assess the use of breast massage to manage breast lymphedema. Developing non-invasive image-based methods may enable researchers to map the extent of lymphedema, monitor its progression and evaluate therapies. This may allow for improved quantitate measures to be undertaken to better assess future strategies intended to prevent or improve the management of this treatment complication.
Patients participating in this study will have ultrasound scans before and after the massage. They will also be asked to complete a questionnaire.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: