An interventional study of 3D surface scan in Breast Cancer Female and Adjuvant Radiotherapy, sponsored by Centre Paul Strauss. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-12.
Sponsored by Centre Paul Strauss · Not applicable, Interventional, and Other
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.
Centre Paul Strauss is the lead sponsor of 30 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Device: 3D surface scan
measurement of inter fractional deformations by surface scanning
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.
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)
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)
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)
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
Time frame: 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
Time frame: before treatment start
Required measurement time (surface scan)
Mean time (in minutes) needed to perform a 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)
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)
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)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Centre Paul Strauss