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

NCT02916719 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-07-22

No results posted yet for this study

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

Interventions

DEVICE

MRI

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

Sponsors & Collaborators

  • Brugmann University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-21
Primary Completion
2022-03-03
Completion
2022-03-03

Countries

  • Belgium

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02916719 on ClinicalTrials.gov