NCT02798484

Monitoring of Breast Cancers Treated by Neoadjuvant Therapy Via Diffusion-weighted Magnetic Resonance Imaging

Completed NA Last updated 18 January 2020

What this trial tests

NA trial testing Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI) in Breast Cancer in 61 participants. Completed in 31 January 2019.

Timeline

21 June 2016

Primary endpoint
1 January 2019

31 January 2019

Quick facts

Lead sponsor	Brugmann University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	61
Start date	21 June 2016
Primary completion	1 January 2019
Estimated completion	31 January 2019
Sites	1 location across Belgium

Drugs / interventions tested

• Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI)

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Brugmann University Hospital

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

The investigator's goal for this study is to evaluate the reliability of diffusion as tumor biomarker. Therefore, they will study the quantitative analysis of the diffusion-weighted magnetic resonance sequences in the pre-therapeutic assessment and the early and late follow-up of breast cancers under neoadjuvant treatment (chemotherapy, hormonotherapy...) within the CHU Brugmann hospital. The results of this analysis will be compared with the MRI results obtained at the end of the treatment and with the histology of the initial biopsy and the surgical specimen.

The expected benefits are:

* to establish correlations between apparent diffusion coefficients (ADC) values and histology
* to observe changes in the ADC according to the type of response: ADC increase in the event of partial response, ADC stability in the event of non response, ADC decrease in the event of a progression, absence of restriction in the event of a complete response.
* to confirm that diffusion weighted MRI within a short interval (after one cure, at one month) has a predictive value for the neoadjuvant chemotherapy (NAC) response.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Assessment of diffusion-weighted MRI in predicting response to neoadjuvant chemotherapy in breast cancer patients.
   Hottat NA, Badr DA, Lecomte S, Besse-Hammer T, et al · · 2023 · cited 11× · PMID 36635514 · DOI 10.1038/s41598-023-27787-x
2. Imaging markers of response to combined BRAF and MEK inhibition in BRAF mutated vemurafenib-sensitive and resistant melanomas.
   Acciardo S, Mignion L, Joudiou N, Bouzin C, et al · · 2018 · cited 4× · PMID 29682188 · DOI 10.18632/oncotarget.24709