The Effect of Tumor - Breast Volume Ratio on Cosmetic and Functional Outcomes in Breast Conserving Surgery Patients; a Prospective Cohort Study
N/A
70 Years
Female
Breast Cancer
Trial Information
The Effect of Tumor - Breast Volume Ratio on Cosmetic and Functional Outcomes in Breast Conserving Surgery Patients; a Prospective Cohort Study
Inclusion Criteria:
- early breast cancer
- unilateral tumor
- tumor size is less than 3 cm
Exclusion Criteria:
- age over 70
- malignant invasive tumor in the past
- pregnancy
- previous surgical treatment of the breast or axilla
- central breast tumor sizing <3 cm
- a need for mastectomy
- tumor size >3 cm measured by mammography or physical examination
- surgical excisions resulting in positive margins
- surgical or radiotherapeutic complication
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Primary outcome is the determination of the critical tumor / breast volume ratio in each quadrant, above of which number breast conserving surgery could not offer adequate cosmetic and functional results.
Outcome Description:
Data of eligible patients are recorded by the study physicians on a locally developed questionnaire. Digital photos are taken of each patient producing a frontal and two side views. Images are processed by the BCCT.core software (Breast Cancer Conservation Treatment. cosmetic results). Magnetic resonance imaging is implemented and used to calculate breast volume with the help of Amira 5.1 software (Visage Imaging GmbH)trial version. Excised tumor is measured by a validated analytical scale.
Outcome Time Frame:
8 months
Safety Issue:
No
Authority:
Hungary: Institutional Ethics Committee
Study ID:
NIO-BCS-QoL
NCT ID:
NCT01496001
Start Date:
March 2011
Completion Date:
Related Keywords:
- Breast Cancer
- Early unilateral breast cancer
- Breast Neoplasms
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