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Completed

NCT Number: NCT03801850

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

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Key information

Conditions

Breast Cancer Female Adjuvant Radiotherapy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre paul Strauss

Strasbourg, 67065, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D surface scan

Device

measurement of inter fractional deformations by surface scanning

Primary outcomes

  1. Impact of breast morphology or volume changes during the breast irradiation on the total dose administered

    Time frame: 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 outcomes

  1. Preliminary quantitative assessment of breast volume changes (mL) during breast radiotherapy following breast cancer conservative surgery

    Time frame: 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)

  2. Preliminary quantitative assessment of breast deformations (mm) during breast radiotherapy following breast cancer conservative surgery

    Time frame: 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)

  3. Breast deformation and volume measurements reproducibility

    Time frame: 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

  4. Deviation between the breast volume calculated and the breast volume manually delineated

    Time frame: before treatment start

    Evaluation of the difference between the initial breast volume calculated by the software developed for the study and the delineated volume

  5. Required measurement time (surface scan)

    Time frame: 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

  6. Correlation between textural data and radio-induced erythema

    Time frame: 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)

  7. Potential dose distribution alteration despite no variation of the 95Recalculated or the D2Recalculated

    Time frame: at the end of each treatment (at 5 weeks for in-situ carcinoma and at 6.5 weeks for invasive carcinoma)

Sponsors and collaborators

Lead sponsor

Centre Paul Strauss

Other

Registry information

Official study title

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

Acronym: MB3D

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 14, 2019
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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