Clinical trial NCT02916719: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: neo-adjuvant radiotherapy
breast cancer
MRI
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


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

Primary outcomes:
measure: Anatomo-pathology classification - histological type
timeFrame: Between 2 to 8 days after last radiotherapy session
measure: Apparent diffusion coefficient (ADC) (mm2/sec)
timeFrame: Baseline (before radiotherapy)
measure: Apparent diffusion coefficient (ADC) (mm2/sec)
timeFrame: Between 2 to 8 days after last radiotherapy session
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
References: