Breast Cancer Female Clinical Trial
— MB3DOfficial title:
Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: Monocentric Feasibility Study MorphoBreast3D
Verified date | August 2020 |
Source | Centre Paul Strauss |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 7, 2020 |
Est. primary completion date | May 7, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Centre paul Strauss | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
Centre Paul Strauss |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | ||
Secondary | 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) | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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) | |
Secondary | 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) | ||
Secondary | 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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03080623 -
Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
|
||
Completed |
NCT05527769 -
Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique
|
||
Completed |
NCT06376578 -
Exercise Interventions for Improving Health in Breast Cancer Survivors
|
N/A | |
Completed |
NCT03004534 -
A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide
|
Early Phase 1 | |
Recruiting |
NCT05020574 -
Microbiome and Association With Implant Infections
|
Phase 2 | |
Active, not recruiting |
NCT06277141 -
The Vitality Mammography Messaging Study
|
N/A | |
Completed |
NCT03270111 -
High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women
|
N/A | |
Completed |
NCT03555227 -
USG PECS vs LIA for Breast Cancer Surgery
|
N/A | |
Active, not recruiting |
NCT03917082 -
Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05561842 -
Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)
|
||
Completed |
NCT04554056 -
Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT03127995 -
Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence
|
N/A | |
Active, not recruiting |
NCT02237469 -
Prone Breast Radiotherapy Treatment Planning Observational Study
|
||
Completed |
NCT01204125 -
Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients
|
Phase 2 | |
Recruiting |
NCT04565054 -
Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC
|
Phase 3 | |
Not yet recruiting |
NCT06412133 -
Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients
|
N/A | |
Recruiting |
NCT03956641 -
Evolution of the Physical Condition in Treated Cancer Patients
|
N/A | |
Recruiting |
NCT06087120 -
Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
|
||
Recruiting |
NCT06058936 -
Exercises Using Virtual Reality on Cancer Patients
|
N/A | |
Completed |
NCT03470935 -
Non-interventional Study Evaluating Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger
|