NCT02449824

MRI and Early Decision-making in Chemotherapy for Breast Cancer

Characterising Early Response to Neoadjuvant Chemotherapy With Quantitative Breast MRI

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: University of Leeds · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Firstly, the investigators aim to show that breast tumour blood flow, measured as part of a standard MRI examination, decreases at the earliest stage of neoadjuvant chemotherapy in those patients who go on to respond to treatment. Importantly, the investigators will also show that blood flow does not decrease in those patients who fail to respond. Secondly, the investigators will test whether the decrease in tumour blood flow over the whole course of neoadjuvant chemotherapy can predict the response of the tumour measured at the time of surgery.

Detailed description

i) Background. In a recent pilot study of 18 patients undergoing neoadjuvant chemotherapy (NAC), the investigators demonstrated for the first time that it was feasible to measure breast tumour blood flow (TBF) as part of a standard clinical MRI exam. TBF decreased dramatically in clinical responders and when compared with similar results obtained by others using \[15-O\] H2O positron emission tomography, the data led the investigators to hypothesise that TBF will decrease after only 1 cycle of NAC in responders. The data also suggested that changes in TBF over the course of NAC might predict pathological response. ii) Aims. The primary aim is to assess response to first line NAC non-invasively after only 1 cycle of treatment. A secondary aim is to predict pathological response based upon changes measured over the course of NAC. iii) Techniques and Methodology. The investigators will measure TBF using a novel MRI approach in 40 patients studied before, following 1 cycle, at the mid-point and the end of a fixed course of NAC. The MRI data will be compared with histological and molecular markers, obtained from biopsies at baseline and after 1 cycle of NAC and from specimens obtained during surgery at the end of NAC, to assess mechanisms of response to chemotherapy. In a sub-study of 10 patients imaged twice at baseline the investigators will assess the reproducibility of the TBF measures. iv) Impact on breast cancer research. These techniques will provide absolute measures of tumour function during therapy which will particularly benefit non-responders to first line NAC allowing clear and objective decisions to be made about possible early changes in their treatment.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
OTHER	magnetic resonance imaging	early MRI

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-10-01
• First posted: 2015-05-20
• Last updated: 2020-11-13

Locations

1 site across 1 country: United Kingdom