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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer Female, Adjuvant Radiotherapy

Intervention / Treatment
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* Device: 3D surface scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: observational cohort<br> | Device: 3D surface scan<br>* measurement of inter fractional deformations by surface scanning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 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 | 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 | before treatment start | 
| Required measurement time (surface scan) | Mean time (in minutes) needed to perform a 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D scan, volume variation, deformation, repositioning, dosimetric quality