Multi-Parametric Assessment of Breast Lymphedema

NCT02724514 | Completed

• 1 other identifier: UHN REB 14-8503-C
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Breast lymphedema (swelling due to fluid) is a common complication of breast cancer therapy. Unlike lymphedema in the arm, breast lymphedema is not as well-known and has not been studied. At present, no objective and standardized tools exist to evaluate breast lymphedema. The purpose of this study is to investigate the use of ultrasound analysis and bio-impedance to determine if it is possible to measure the extent of the fluid in the breast.

Conditions

Breast Cancer; Breast Lymphedema

Outcome Measures

Primary Outcomes (2)

• Measure Mid-Band Fit (MBF) in normal tissue controls and the corresponding regions of lymphedema

  The MBF, measured in dB, is a quantitative ultra-sound (QUS) image parameter used to characterize tissue microstructure

  2 years

• Measure Acoustic Scatterer Diameter (ASD) in normal tissue controls and the corresponding regions of lymphedema

  The ASD, measured in mm, is a quantitative ultra-sound (QUS) image parameter used to characterize tissue microstructure

  2 years

Interventions

non-invasive image & bioimpedance based techniques OTHER

Ultrasound scans, bioimpedance measurements, clinical photographs and questionnaires will be performed before and after the massage.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast lymphedema Cancer patients with lymphedema

You may qualify if:

• At least 18 y/o
• Diagnosis of lymphedema involving the breast
• Diagnosis of in-situ or invasive breast cancer
• Female patients following breast conserving therapy and radiotherapy
• Spoken and written fluency in English; and
• Able to provide informed consent

You may not qualify if:

• Pacemaker or implanted stimulator or other contraindication to bioimpedance analysis
• Prior breast surgery on the contra lateral breast
• Presence of active cellulitis within the breast, trunk or arm and
• Presence of active cancer

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robert Dinniwall, MD

  UHN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 31, 2016
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 3, 2019
• Last Updated: November 27, 2019

Record last verified: 2019-11

Locations

CA (1)