Clinical trial · Interventional
Monitoring of Breast Cancers Treated by Neoadjuvant Radiotherapy Via Magnetic Resonance Imaging
- 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)
Magnetic resonance imaging (MRI) is the method of choice in breast cancer to perform the loco-regional staging and direct the treatment. European Guidelines (EUSOMA) currently recommend MRI for initial evaluation and assessement of the neoadjuvant chemotherapy (NAC) response, for breast cancer. The standard of care consists of realizing a MRI before the start of the NAC and another one after it's ended, six months later. There is currently no consensus on the realization of an interval MRI for early assessment of the chemosensitivity of the tumor. It would allow though alterations in the therapeutic regimen in the event of a non response. Similarly, there is no consensus on when this interval MRI should be performed. Some recent studies suggest that Diffusion-weighted Magnetic Resonance Imaging is interesting for the evaluation of the early response. However, these are preliminary studies with quantitative measures realized by the region of interest (ROI) method. A response to neoadjuvant chemotherapy results in elevated values of apparent diffusion coefficients (ADC). There is'nt any published data on the potential interest of breast MRI after a radiotherapy treatment and before the surgical treatment. Therefore, the expected benefits of this study are: * to monitor the early modifications of the perfusion and diffusion parameters at the level of the tumor after radiotherapy, and correlate them to the histology of the surgical monster. * to assess if MRI is able to objectivate the early signs of response after a radiotherapy neo-adjuvant treatment of breast cancer. This record is linked to the NCT02858934 record and will share the same cohort of patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neo-adjuvant radiotherapy
- description
- Group of women having undergone a neo-adjuvant radiotherapy for early breast cancer.
- interventionNames
- Device: MRI
Primary outcomes (3)
- measure
- Anatomo-pathology classification - histological type
- timeFrame
- Between 2 to 8 days after last radiotherapy session
- description
- The histological type of the tumor will be determined by the Anatomo-Pathology Department of the CHU Brugmann hospital, according to standard of care. The determination will be performed on the initial biopsy samples used for diagnosis and/or on the surgical specimen
- measure
- Apparent diffusion coefficient (ADC) (mm2/sec)
- timeFrame
- Baseline (before radiotherapy)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Histological diagnosis of unifocal invasive breast carcinoma, no special type (ductal carcinoma) * Tumor Staging: cT1-2N0M0 * Luminal A or B * Candidate for breast conserving surgery * N0-status confirmed by lymph node cytology Exclusion Criteria: * Multifocal/multicentric disease * Prior thoracic radiotherapy * Pregnancy * SBR3 grading * Triple negative status which benefit neoadjuvant chemotherapy
References
Publications (0)
Data not yet available