Clinical trial · Interventional
Monitoring of Breast Cancers Treated by Neoadjuvant Therapy Via Diffusion-weighted Magnetic Resonance Imaging
Pilot Study: Monitoring of Breast Cancers Treated by Neoadjuvant Therapy Via Diffusion-weighted 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). The investigator's goal for this study is to evaluate the reliability of diffusion as tumor biomarker. Therefore, they will study the quantitative analysis of the diffusion-weighted magnetic resonance sequences in the pre-therapeutic assessment and the early and late follow-up of breast cancers under neoadjuvant treatment (chemotherapy, hormonotherapy...) within the CHU Brugmann hospital. The results of this analysis will be compared with the MRI results obtained at the end of the treatment and with the histology of the initial biopsy and the surgical specimen. The expected benefits are: * to establish correlations between apparent diffusion coefficients (ADC) values and histology * to observe changes in the ADC according to the type of response: ADC increase in the event of partial response, ADC stability in the event of non response, ADC decrease in the event of a progression, absence of restriction in the event of a complete response. * to confirm that diffusion weighted MRI within a short interval (after one cure, at one month) has a predictive value for the neoadjuvant chemotherapy (NAC) response.
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 |
|---|---|---|---|
| Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast cancer
- description
- Patients diagnosed with breast cancer and placed under neo-adjuvant treatment (hormonotherapy, chemotherapy) within the CHU Brugmann hospital.
- interventionNames
- Device: Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI)
Primary outcomes (4)
- measure
- Apparent diffusion coefficient (ADC) (mm2/sec)
- timeFrame
- Baseline: start of the neo-adjuvant therapy
- description
- Apparent diffusion coefficient (ADC) expressed in mm2/sec. Magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens).Post-processing realized with the Syngo Onco Care application of Siemens.
- measure
- Apparent diffusion coefficient (ADC) (mm2/sec)
- timeFrame
- One month after the start of the neo-adjuvant therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer * Neo-adjuvant therapy indication * Performance status from 0 to 2 Exclusion Criteria: * Contraindications to magnetic resonance imaging (pacemaker, nerve stimulator, cochlear implant, major claustrophobia) * Absence of histological results * Disruption of the neo-adjuvant therapy
References
Publications (9)
- BACKGROUNDFiorentino C, Berruti A, Bottini A, Bodini M, Brizzi MP, Brunelli A, Marini U, Allevi G, Aguggini S, Tira A, Alquati P, Olivetti L, Dogliotti L. Accuracy of mammography and echography versus clinical palpation in the assessment of response to primary chemotherapy in breast cancer patients with operable disease. Breast Cancer Res Treat. 2001 Sep;69(2):143-51. doi: 10.1023/a:1012277325168. PMID 11759820
- BACKGROUNDVinnicombe SJ, MacVicar AD, Guy RL, Sloane JP, Powles TJ, Knee G, Husband JE. Primary breast cancer: mammographic changes after neoadjuvant chemotherapy, with pathologic correlation. Radiology. 1996 Feb;198(2):333-40. doi: 10.1148/radiology.198.2.8596827. PMID 8596827
- BACKGROUNDHuber S, Wagner M, Zuna I, Medl M, Czembirek H, Delorme S. Locally advanced breast carcinoma: evaluation of mammography in the prediction of residual disease after induction chemotherapy. Anticancer Res. 2000 Jan-Feb;20(1B):553-8. PMID 10769724
- BACKGROUNDBalu-Maestro C, Chapellier C, Bleuse A, Chanalet I, Chauvel C, Largillier R. Imaging in evaluation of response to neoadjuvant breast cancer treatment benefits of MRI. Breast Cancer Res Treat. 2002 Mar;72(2):145-52. doi: 10.1023/a:1014856713942. PMID 12038705
- BACKGROUNDSardanelli F, Boetes C, Borisch B, Decker T, Federico M, Gilbert FJ, Helbich T, Heywang-Kobrunner SH, Kaiser WA, Kerin MJ, Mansel RE, Marotti L, Martincich L, Mauriac L, Meijers-Heijboer H, Orecchia R, Panizza P, Ponti A, Purushotham AD, Regitnig P, Del Turco MR, Thibault F, Wilson R. Magnetic resonance imaging of the breast: recommendations from the EUSOMA working group. Eur J Cancer. 2010 May;46(8):1296-316. doi: 10.1016/j.ejca.2010.02.015. Epub 2010 Mar 19. PMID 20304629
- BACKGROUNDWu LM, Hu JN, Gu HY, Hua J, Chen J, Xu JR. Can diffusion-weighted MR imaging and contrast-enhanced MR imaging precisely evaluate and predict pathological response to neoadjuvant chemotherapy in patients with breast cancer? Breast Cancer Res Treat. 2012 Aug;135(1):17-28. doi: 10.1007/s10549-012-2033-5. Epub 2012 Apr 4.