NCT02916719

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2022

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

5.7 years

First QC Date

September 26, 2016

Last Update Submit

July 19, 2022

Conditions

Breast Cancer

Keywords

neo-adjuvant radiotherapybreast cancerMRI

Outcome Measures

Primary Outcomes (3)

  • 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

    Between 2 to 8 days after last radiotherapy session

  • 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 (before radiotherapy)

  • 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.

    Between 2 to 8 days after last radiotherapy session

Study Arms (1)

Neo-adjuvant radiotherapy

EXPERIMENTAL

Group of women having undergone a neo-adjuvant radiotherapy for early breast cancer.

Device: MRI

Interventions

MRIDEVICE

MRI examination after the neo-adjuvant radiotherapy, but before the surgical treatment

Neo-adjuvant radiotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Multifocal/multicentric disease
  • Prior thoracic radiotherapy
  • Pregnancy
  • SBR3 grading
  • Triple negative status which benefit neoadjuvant chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

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 clinic

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 27, 2016

Study Start

June 21, 2016

Primary Completion

March 3, 2022

Study Completion

March 3, 2022

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)