Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: MorphoBreast3D (MB3D)

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

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 Overview

• Status: Completed
• Conditions: Breast Cancer Female; Adjuvant Radiotherapy
• Intervention / Treatment: Device: 3D surface scan

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67065
    • Centre Paul Strauss

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: observational cohort	Device: 3D surface scan; measurement of inter fractional deformations by surface scanning

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Centre Paul Strauss
• Investigators: Principal Investigator: Georges NOEL, MD PhD, Centre Paul Strauss

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2018
• Primary Completion (Actual): May 7, 2020
• Study Completion (Actual): May 7, 2020

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: 3D scan; volume variation; deformation; repositioning; dosimetric quality
• Other Study ID Numbers: 2018-01; 2017-A02489-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No