Breast Neoplasm Malignant Breast Tissue Clinical Trial
Official title:
What Are the Factors Affecting Neoadjuvant Chemotherapy Efficacy in Breast Cancer? A Non-invasive in Vivo Study Using Specialist Magnetic Resonance (MR) Methods
Breast cancer is the most prevalent cancer affecting women. To treat locally advanced breast
cancers, neoadjuvant chemotherapy (NACT) is often carried out before surgery to reduce the
tumour size to allow breast conservation surgery. However, treatment response for individual
patients varies, where the tumour may not respond to treatment and the quality of patient
care is compromised if the NACT treatment plan is not optimised. Therefore, the assessment of
NACT efficacy is beneficial for the early identification of these patients and appropriate
management of treatment.
Breast tumours have unique features compared to healthy tissue, including abnormal tissue
structure and biochemical composition. With NACT there are specific changes to such tumour
features indicating tumour treatment response.
The purpose of this study is to establish how the changes to breast tumour features following
NACT treatment are seen in non-invasive imaging. This study will look at scans of breast
tumours using magnetic resonance imaging (MRI). Changes to tissue structure will be measured
by advanced diffusion MRI techniques and changes to tumour related biochemical substances
will be measured by advanced magnetic resonance spectroscopy techniques. The investigators
aim to assess if these techniques can provide information on the tumour treatment response
following subsequent rounds of NACT treatment.
In this longitudinal study, 25 patients undergoing NACT will be recruited for four repeated
MRI investigations over the course of NACT treatment. Magnetic resonance (MR) measurements of
tissue microstructure and biochemical composition will be compared against histological
measurements and radiological assessments of treatment response.
The study will recruit patients undergoing treatment at the NHS Grampian. This research is
funded by Friends of ANCHOR, Tenovus Scotland Grampian and the NHS Grampian Endowment
Research Fund.
In this single group longitudinal study, the investigators propose that functional images
from magnetic resonance (MR) methods performed at baseline and after 6 cycles of neoadjuvant
chemotherapy (NACT) are in agreement with histological findings from pre-treatment biopsy and
post-treatment surgically excised tissue. MR methods will be performed at baseline
(pre-treatment) and after the 1st, 3rd and 6th (post-treatment) cycles of NACT treatment. The
investigators hypothesise that specific physiological changes detected through MR methods are
a manifestation of tumour response to NACT confirmed by histology and radiological assessment
(Hypothesis 1). The investigators further hypothesise that early sensitivity to physiological
changes manifesting from tumour response to NACT can be revealed by MR measurements after the
first and third cycle of treatment (Hypothesis 2).
Research Question 1: Is there a difference in physiological parameters revealed by MR
measurements at baseline and after completion of NACT?
Research Question 2: Do the physiological measurements at the completion of NACT from MR
measures agree with histological findings?
Research Question 3: Is there a difference between MR measurements at baseline and after the
first and third cycle of NACT?
Research Question 4: Is there a difference in MR measurements at baseline, first and third
cycle of NACT, between positive treatment responders and non-responders.
MR measurements will be compared against clinical and study specific results from
histological analysis and radiological assessment of MRI, mammography and ultrasound measures
of tumour treatment response. Information collected from a health questionnaire will
supplement interpretation of the data.
To test the effects of NACT on specific aspects of tumour physiology, paired t-tests will be
performed on MR measures of lactate concentration, lipid composition and diffusion
parameters, between baseline and post-treatment assessments (Research Question 1).
To examine the relationship between MR measurements and histology, correlation analysis will
be conducted between baseline and post-treatment assessments. MR measures will be correlated
against corresponding percentage changes in histological findings between biopsy and tumour
excision (Research Question 2).
To evaluate MR measures as early markers of NACT efficacy, paired t-tests will be carried out
between MR measures at pre-treatment and post 1st and 3rd cycles of NACT treatment (Research
Question 3), with independent group difference determined between responders and
non-responders (Research Question 4).
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