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

Centre Paul Strauss60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Breast Cancer Female Adjuvant Radiotherapy

Interventions

3D surface scanDEVICE

measurement of inter fractional deformations by surface scanning

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women * 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 * Patient under safeguard of justice

Locations (1)

Centre paul Strauss

Strasbourg, France

Outcomes

Primary Outcomes

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

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.

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)

Secondary Outcomes

Preliminary quantitative assessment of breast volume changes (mL) during breast radiotherapy following breast cancer conservative surgery

Time frame: 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

Time frame: 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

Evaluation of the reproducibility of deformation and volume measurements between 2 consecutive surface scan acquisition. Reproducibility was calculated in accordance with International Organization of Standardisation (ISO 5725-2) and American Society for Testing and Material E177

Time frame: before treatment start

Deviation between the breast volume calculated and the breast volume manually delineated

Evaluation of the difference between the initial breast volume calculated by the software developed for the study and the delineated volume

Time frame: before treatment start

Data from ClinicalTrials.gov

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