search
Back to results

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
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 neo-adjuvant radiotherapy, breast cancer, MRI

Eligibility Criteria

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

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

First Posted
September 26, 2016
Last Updated
July 19, 2022
Sponsor
Brugmann University Hospital
search

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

We'll reach out to this number within 24 hrs