Clinical trial · Interventional
Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: MorphoBreast3D
Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: Monocentric Feasibility Study MorphoBreast3D
NCT03801850CI-TRIAL-00046580MB3DcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Radiotherapy | — | UNRESOLVED | — |
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D surface scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- observational cohort
- interventionNames
- Device: 3D surface scan
Primary outcomes (1)
- measure
- Impact of breast morphology or volume changes during the breast irradiation on the total dose administered
- timeFrame
- 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)
- description
- 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 (7)
- measure
- Preliminary quantitative assessment of breast volume changes (mL) during breast radiotherapy following breast cancer conservative surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGalmiche 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. PMID 42376805