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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Device

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

Primary outcomes

Anatomo-pathology classification - histological type

Time frame: Between 2 to 8 days after last radiotherapy session

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)

Time frame: Baseline (before radiotherapy)

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)

Time frame: Between 2 to 8 days after last radiotherapy session

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.

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2022
Study completion: 2022
First posted: Sep 27, 2016
Registry last updated: Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed