Head and Neck Cancer Clinical Trial
Official title:
Oxygen Enhanced MRI Measurement in Head and Neck Cancer: Validation and Efficacy of Response.
This is a prospective pilot study to investigate the potential clinical value of oxygen-enhanced magnetic resonance (OE-MRI) biomarkers in head and neck radiotherapy.
This is a prospective pilot study funded by the NIHR. Healthy participants and patients will
be recruited in The Christie NHS Foundation Trust and will be asked to undergo
oxygen-enhanced magnetic resonance imaging (OE-MRI) and dynamic contrast-enhanced MRI
(DCE-MRI). This study builds on the work recently been completed in lung cancer. Clinical
data will be collected from patients notes.
Tumour hypoxia is common in solid tumours and associated with poor response to radiotherapy,
poor loco-regional control and survival outcomes in head and neck cancer. There is a need to
develop non-invasive tests that can measure tumour hypoxia to improve radiotherapy for these
patients. The study will involve 3 components:
1. Reproducibility and feasibility: The reproducibility of OE-MRI in head and neck cancer
is unknown. Ten healthy participants will be asked to undergo two baseline OE-MRI scans
with either nasal cannula or facial mask to breathe air and oxygen throughout. The order
of which non-invasive breathing method will be used first will be randomized.
Following this initial pilot OE-MRI will be tested in 30 patients with solid head and
neck tumours. To assess reproducibility in patients 2 OE-MRI will be performed at
baseline.
2. Effect of radiotherapy on tumour and normal tissue: OE-MRI and DCE-MRI signals will be
measured at baseline before standard radiotherapy treatment begins and at the end of
week 2 week and week 4 following the start of radiotherapy. Comparison of hypoxia
measurements will be taken.
3. Biological validation: All 30 patients will undergo a diagnostic biopsy as standard of
care at their local hospital. Tissue samples will be requested and multi-gene hypoxia
signatures will be tested. OE-MRI signals will be compared with tissue sample from the
same patient and the presence of changes in tumour known to be associated with hypoxia
will be analysed.
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