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

NCT03801850 | Completed

• 2 other identifiers: 2018-012017-A02489-44
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female; Adjuvant Radiotherapy

Keywords

volume variation; deformation; repositioning; dosimetric quality; 3D scan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

  before treatment start

• Deviation between the breast volume calculated and the breast volume manually delineated

  before treatment start

• 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)

Study Arms (1)

observational cohort

EXPERIMENTAL

Device: 3D surface scan

Interventions

3D surface scan DEVICE

measurement of inter fractional deformations by surface scanning

observational cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Surgical treatment by mastectomy
• No indication for breast radiotherapy
• 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

Sponsors & Collaborators

• Centre Paul Strauss: lead

Study Sites (1)

Centre paul Strauss

Strasbourg, 67065, France

Location

Study Officials

• Georges NOEL, MD PhD

  Centre Paul Strauss

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: January 14, 2019
• Study Start: February 22, 2018
• Primary Completion: May 7, 2020
• Study Completion: May 7, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

FR (1)