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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A02489-44 | Other Identifier | ANSM |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| observational cohort | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D surface scan | Device | measurement of inter fractional deformations by surface scanning |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Georges NOEL, MD PhD | Centre Paul Strauss | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre paul Strauss | Strasbourg | 67065 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42376805 | Derived | Galmiche P, Seo H, Pin Y, Meyer P, Noel G, De Mathelin M. Surface-guided analysis of breast shape changes during postoperative radiotherapy by using a functional map framework. Med Phys. 2026 Jul;53(7):e70532. doi: 10.1002/mp.70532. |
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| 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) |