Monitoring of Breast Cancers Treated by Neoadjuvant Radiotherapy Via Magnetic Resonance Imaging

NCT ID: NCT02916719

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-21
• Study Completion Date: 2022-03-03

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

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Neo-adjuvant radiotherapy

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

Group Type: EXPERIMENTAL

MRI

Intervention Type: DEVICE

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

Interventions

MRI

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brugmann University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mieke Cannie

Head of clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHU Brugmann

Brussels, , Belgium

Countries

Belgium

Other Identifiers

CHUB-PreopBreast-IRM

Identifier Type: -

Identifier Source: org_study_id