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

Not Applicable

Completed

• Conditions: Adjuvant Radiotherapy; Breast Cancer Female
• Interventions: Device: 3D surface scan

• Registration Number: NCT03801850
• Lead Sponsor: Centre Paul Strauss

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-22
• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2019-01-09
• Study First Posted: 2019-01-14
• Primary Completion: 2020-05-07
• Study Completion: 2020-05-07
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
observational cohort	3D surface scan	-

Primary Outcome Measures

Name	Time	Method
Impact of breast morphology or volume changes during the breast irradiation on the total dose administered	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 Outcome Measures

Name	Time	Method
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	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
Deviation between the breast volume calculated and the breast volume manually delineated	before treatment start	Evaluation of the difference between the initial breast volume calculated by the software developed for the study and the delineated volume
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)	Mean time (in minutes) needed to perform a surface scan

Trial Locations

Locations (1)

Centre paul Strauss; 🇫🇷 Strasbourg, France