Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: Monocentric Feasibility Study MorphoBreast3D

Centre Paul Strauss1 site in 1 country60 target enrollmentFebruary 22, 2018

ConditionsBreast Cancer Female Adjuvant Radiotherapy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer Female
Sponsor: Centre Paul Strauss
Enrollment: 60
Locations: 1
Primary Endpoint: Impact of breast morphology or volume changes during the breast irradiation on the total dose administered
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Quantitative evaluation of the breast's morphological variations during radiotherapy consisting in performing three-dimensional surface acquisitions of the breast in order to study its shape and volume. Evaluation of the dosimetric impact of these variations.

Registry

clinicaltrials.gov

Start Date

February 22, 2018

End Date

May 7, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Centre Paul Strauss

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•In situ or invasive breast carcinoma
•Treated by conservative breast surgery
•Pre-treatment with authorized chemotherapy
•Eligible for conventional breast irradiation in 25 sessions of 2 Gy with or without irradiation of the tumor bed and lymph nodes area
•Conventional 3D radiotherapy technique
•Bra cup size from A to D included
•Speaking and understanding french
•Having given written consent
•Patient with health insurance

Exclusion Criteria

•Surgical treatment by mastectomy
•No indication for breast radiotherapy
•Local or diffuse inflammatory state of the breast at inclusion
•History of epilepsy or anticonvulsive treatment for preventive or curative purposes
•BMI\> 30kg / m2
•T4 stage tumor
•Bilateral breast tumor
•Use of a ventilatory control to treat the patient
•Minor patient or major incompetent
•Patient deprived of liberty

Outcomes

Primary Outcomes

Impact of breast morphology or volume changes during the breast irradiation on the total dose administered

Time Frame: Change of the dose delivered in the breast from the baseline treatment planification at the end of the treatment (at 5 weeks for in-situ carcinoma and at 6.5 weeks for invasive carcinoma)

To analyse the effect of morphological changes in the breast during breast radiotherapy on the dose really administered in the remaining mammary gland after breast-conserving surgery compared to the dose initially planned.

Secondary Outcomes

Preliminary quantitative assessment of breast volume changes (mL) during breast radiotherapy following breast cancer conservative surgery(At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33))
Correlation between textural data and radio-induced erythema(At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33))
Preliminary quantitative assessment of breast deformations (mm) during breast radiotherapy following breast cancer conservative surgery(At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33))
Breast deformation and volume measurements reproducibility(before treatment start)
Deviation between the breast volume calculated and the breast volume manually delineated(before treatment start)
Potential dose distribution alteration despite no variation of the 95Recalculated or the D2Recalculated(at the end of each treatment (at 5 weeks for in-situ carcinoma and at 6.5 weeks for invasive carcinoma))
Required measurement time (surface scan)(At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33))