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

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ClinicalTrials.gov Identifier: NCT02798484
Recruitment Status : Completed
First Posted : June 14, 2016
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Mieke Cannie, Brugmann University Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study: Monitoring of Breast Cancers Treated by Neoadjuvant Therapy Via Diffusion-weighted Magnetic Resonance Imaging
Actual Study Start Date : June 21, 2016
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Breast cancer
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)
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.




Primary Outcome Measures :
  1. Apparent diffusion coefficient (ADC) (mm2/sec) [ Time Frame: Baseline: start of the neo-adjuvant therapy ]
    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.

  2. Apparent diffusion coefficient (ADC) (mm2/sec) [ Time Frame: One month after the start of the neo-adjuvant therapy ]
    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.

  3. Apparent diffusion coefficient (ADC) (mm2/sec) [ Time Frame: At the end of the neo-adjuvant therapy (typical duration: 6 months) ]
    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.

  4. Anatomo-pathology classification - histological type [ Time Frame: Baseline: start of the neo-adjuvant therapy ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02798484


Locations
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Belgium
CHU Brugmann
Brussels, Belgium, 1020
Sponsors and Collaborators
Brugmann University Hospital
Investigators
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Principal Investigator: Mieke Cannie, MD CHU Brugmann
Principal Investigator: Nathalie Hottat, MD CHU Brugmann
Publications:

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Responsible Party: Mieke Cannie, Head of service, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02798484    
Other Study ID Numbers: CHUB-CNA
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Keywords provided by Mieke Cannie, Brugmann University Hospital:
Diffusion Weighted Magnetic Resonance Imaging
Breast cancer
Neo-adjuvant therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Body Weight
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases