MRI and Early Decision-making in Chemotherapy for Breast Cancer

NCT ID: NCT02449824

Last Updated: 2020-11-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-31

Brief 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

Keywords

neoadjuvant chemotherapy; magnetic resonance imaging

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

magnetic resonance imaging

Participants will undergo MRI at baseline, after 1 cycle, 3 cycles and at completion of neoadjuvant chemotherapy.

magnetic resonance imaging

Intervention Type: OTHER

early MRI

Interventions

magnetic resonance imaging

early MRI

Intervention Type: OTHER

Other Intervention Names

MRI

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed large but operable invasive carcinoma of the breast. All molecular subtypes are eligible and incidentally detected small volume metastatic disease is NOT an exclusion criterion.
• Clinical indication for NAC as determined by the Breast Therapeutic MDT.
• Sufficient biopsy material taken at diagnosis to measure the standard molecular markers.
• Participant is willing and able to give informed consent for participation in the study.
• Female, aged 18 years or above.
• Histologically or cytologically confirmed invasive carcinoma of the breast and having received no prior treatment for this.
• Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
• Participant has adequate renal function (estimated glomerular filtration rate ≥ 30 ml/min).
• In the Investigator's opinion, is able and willing to comply with all study requirements.

Exclusion Criteria

• Previous breast cancer treated with radiotherapy or chemotherapy or recurrent breast cancer.
• Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
• Significant renal impairment (estimated glomerular filtration rate < 30 ml/min).
• Contraindication to MRI.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Leeds

OTHER

Sponsor Role: lead

Responsible Party

David Buckley

Professor of Medical Physics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David L Buckley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Locations

Leeds Teaching Hospitals NHS Trust, St James's University Hospital

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

MO15/085

Identifier Type: -

Identifier Source: org_study_id