Monitoring of Breast Cancers Treated by Neoadjuvant Therapy Via Diffusion-weighted Magnetic Resonance Imaging

NCT02798484 | Completed

• 1 other identifier: CHUB-CNA
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

Diffusion Weighted Magnetic Resonance Imaging; Breast cancer; Neo-adjuvant therapy

Outcome Measures

Primary Outcomes (4)

• Apparent diffusion coefficient (ADC) (mm2/sec)

  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.

  Baseline: start of the neo-adjuvant therapy

• Apparent diffusion coefficient (ADC) (mm2/sec)

  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.

  One month after the start of the neo-adjuvant therapy

• Apparent diffusion coefficient (ADC) (mm2/sec)

  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.

  At the end of the neo-adjuvant therapy (typical duration: 6 months)

• Anatomo-pathology classification - histological type

  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.

  Baseline: start of the neo-adjuvant therapy

Study Arms (1)

Breast cancer

EXPERIMENTAL

Patients diagnosed with breast cancer and placed under neo-adjuvant treatment (hormonotherapy, chemotherapy) within the CHU Brugmann hospital.

Device: Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI)

Interventions

Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI) DEVICE

MRI examinations performed on two devices: Ingernia 3 Testla (Philips) on the Horta site of the CHU Brugmann hospital, and Area 1,5 Tesla (Siemens) on the Brien site of the CHU Brugmann hospital. Diffusion sequences last 6 minutes and are already performed in the standard of care. Compared to the standard of care, one additional MRI will be performed one month after the start of the neo-adjuvant treatment, with diffusion analysis.The post-processing of the examinations will be realized with the Syngo Onco Care application of Siemens.

Breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer
• Neo-adjuvant therapy indication
• Performance status from 0 to 2

You may not qualify if:

• Contraindications to magnetic resonance imaging (pacemaker, nerve stimulator, cochlear implant, major claustrophobia)
• Absence of histological results
• Disruption of the neo-adjuvant therapy

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (9)

• Fiorentino 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 BACKGROUND

• Vinnicombe 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 BACKGROUND

• Huber 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 BACKGROUND

• Balu-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 BACKGROUND

• Sardanelli 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 BACKGROUND

• Wu 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.

  PMID: 22476850 BACKGROUND

• Li XR, Cheng LQ, Liu M, Zhang YJ, Wang JD, Zhang AL, Song X, Li J, Zheng YQ, Liu L. DW-MRI ADC values can predict treatment response in patients with locally advanced breast cancer undergoing neoadjuvant chemotherapy. Med Oncol. 2012 Jun;29(2):425-31. doi: 10.1007/s12032-011-9842-y. Epub 2011 Feb 1.

  PMID: 21286861 BACKGROUND

• Just N. Improving tumour heterogeneity MRI assessment with histograms. Br J Cancer. 2014 Dec 9;111(12):2205-13. doi: 10.1038/bjc.2014.512. Epub 2014 Sep 30.

  PMID: 25268373 BACKGROUND

• Hottat NA, Badr DA, Lecomte S, Besse-Hammer T, Jani JC, Cannie MM. Assessment of diffusion-weighted MRI in predicting response to neoadjuvant chemotherapy in breast cancer patients. Sci Rep. 2023 Jan 12;13(1):614. doi: 10.1038/s41598-023-27787-x.

  PMID: 36635514 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mieke Cannie, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

• Nathalie Hottat, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of service

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 14, 2016
• Study Start: June 21, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 31, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

BE (1)