Clinical trial NCT03801850: Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: MorphoBreast3D
Official title: Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: Monocentric Feasibility Study MorphoBreast3D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Adjuvant Radiotherapy
Keywords: volume variation
deformation
repositioning
dosimetric quality
3D scan
Lead sponsor: Centre Paul Strauss
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Impact of breast morphology or volume changes during the breast irradiation on the total dose administered
timeFrame: 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:
measure: Preliminary quantitative assessment of breast volume changes (mL) during breast radiotherapy following breast cancer conservative surgery
timeFrame: 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)
measure: Preliminary quantitative assessment of breast deformations (mm) during breast radiotherapy following breast cancer conservative surgery
timeFrame: 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)
measure: Breast deformation and volume measurements reproducibility
timeFrame: before treatment start
measure: Deviation between the breast volume calculated and the breast volume manually delineated
timeFrame: before treatment start
measure: Required measurement time (surface scan)
timeFrame: 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)
measure: Correlation between textural data and radio-induced erythema
timeFrame: 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)
measure: Potential dose distribution alteration despite no variation of the 95Recalculated or the D2Recalculated
timeFrame: at the end of each treatment (at 5 weeks for in-situ carcinoma and at 6.5 weeks for invasive carcinoma)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Centre paul Strauss
Study officials:
affiliation: Centre Paul Strauss
name: Georges NOEL, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: