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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI)
Sponsored by
Brugmann University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Diffusion Weighted Magnetic Resonance Imaging, Breast cancer, Neo-adjuvant therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Brugmann

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Breast cancer

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 9, 2016
Last Updated
January 15, 2020
Sponsor
Brugmann University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02798484
Brief Title
Monitoring of Breast Cancers Treated by Neoadjuvant Therapy Via Diffusion-weighted Magnetic Resonance Imaging
Official Title
Pilot Study: Monitoring of Breast Cancers Treated by Neoadjuvant Therapy Via Diffusion-weighted Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 21, 2016 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Diffusion Weighted Magnetic Resonance Imaging, Breast cancer, Neo-adjuvant therapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breast cancer
Arm Type
Experimental
Arm Description
Patients diagnosed with breast cancer and placed under neo-adjuvant treatment (hormonotherapy, chemotherapy) within the CHU Brugmann hospital.
Intervention Type
Device
Intervention Name(s)
Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI)
Intervention Description
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 Measure Information:
Title
Apparent diffusion coefficient (ADC) (mm2/sec)
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.
Time Frame
Baseline: start of the neo-adjuvant therapy
Title
Apparent diffusion coefficient (ADC) (mm2/sec)
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.
Time Frame
One month after the start of the neo-adjuvant therapy
Title
Apparent diffusion coefficient (ADC) (mm2/sec)
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.
Time Frame
At the end of the neo-adjuvant therapy (typical duration: 6 months)
Title
Anatomo-pathology classification - histological type
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.
Time Frame
Baseline: start of the neo-adjuvant therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mieke Cannie, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nathalie Hottat, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
11759820
Citation
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Results Reference
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PubMed Identifier
8596827
Citation
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.
Results Reference
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PubMed Identifier
10769724
Citation
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.
Results Reference
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PubMed Identifier
12038705
Citation
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.
Results Reference
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PubMed Identifier
20304629
Citation
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.
Results Reference
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PubMed Identifier
22476850
Citation
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Results Reference
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PubMed Identifier
21286861
Citation
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.
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Citation
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.
Results Reference
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Monitoring of Breast Cancers Treated by Neoadjuvant Therapy Via Diffusion-weighted Magnetic Resonance Imaging

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