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

Breast Cancer Female Clinical Trial

— MB3D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03801850
• Other study ID #: 2018-01
• Secondary ID: 2017-A02489-44
• Status: Completed
• Phase: N/A
• Start date: February 22, 2018
• Est. completion date: May 7, 2020

Study information

• Verified date: August 2020
• Source: Centre Paul Strauss
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 7, 2020
• Est. primary completion date: May 7, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adjuvant Radiotherapy
• Breast Cancer Female

Intervention

Device:
• 3D surface scan
measurement of inter fractional deformations by surface scanning

Locations

Country	Name	City	State
France	Centre paul Strauss	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre Paul Strauss

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)