Monitoring of Breast Cancers Treated by Neoadjuvant Radiotherapy Via Magnetic Resonance Imaging
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring neo-adjuvant radiotherapy, breast cancer, MRI
Eligibility Criteria
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
Sites / Locations
- CHU Brugmann
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neo-adjuvant radiotherapy
Arm Description
Group of women having undergone a neo-adjuvant radiotherapy for early breast cancer.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02916719
First Posted
September 26, 2016
Last Updated
July 19, 2022
Sponsor
Brugmann University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02916719
Brief Title
Monitoring of Breast Cancers Treated by Neoadjuvant Radiotherapy Via Magnetic Resonance Imaging
Official Title
Monitoring of Breast Cancers Treated by Neoadjuvant Radiotherapy Via Magnetic Resonance Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 21, 2016 (Actual)
Primary Completion Date
March 3, 2022 (Actual)
Study Completion Date
March 3, 2022 (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).
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
neo-adjuvant radiotherapy, breast cancer, MRI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neo-adjuvant radiotherapy
Arm Type
Experimental
Arm Description
Group of women having undergone a neo-adjuvant radiotherapy for early breast cancer.
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
MRI examination after the neo-adjuvant radiotherapy, but before the surgical treatment
Primary Outcome Measure Information:
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
Between 2 to 8 days after last radiotherapy session
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 (before radiotherapy)
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
Between 2 to 8 days after last radiotherapy session
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Monitoring of Breast Cancers Treated by Neoadjuvant Radiotherapy Via Magnetic Resonance Imaging
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