Development and Validation of a Tumour Oxygenation Monitoring Probe

Study Overview
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Brief Summary
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Laboratory based study in which novel tissue oxygenation probe with the potential provide novel means for assessing response to cancer treatment will be developed and validated.

Detailed Description
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Tumour hypoxia is feature common to most solid tumours, with significant implications in tumour aggressiveness, metastatic potential and response to therapy. Tumour oxygenation monitoring is likely, therefore, to provide a valuable adjunct in risk stratification and treatment response monitoring. Diffuse reflectance spectroscopy (DRS) utilises the differing absorption of oxygenated as compared to deoxygenated haemoglobin to provide an accurate measure of tissue oxygenation. This project aims to develop and validate a tissue oxygenation probe for cancer monitoring. Using the clinical paradigms of rectal and breast cancer, anonymised MRIs of cancer sufferers will guide simulations of tissue optical properties to develop a DRS probe. The 3D reconstructed sans will then be used to 3D print tissue phantom models on which the DRS probe will be validated against reference bench top analysers.

Official Title
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Development and Validation of a Tumour Oxygenation Monitoring Probe

Conditions
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Cancer

Intervention / Treatment
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* Device: DRS probe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MRIs from Breast or Rectal Cancer patients (10 of each) Locally advanced Cancers (Stage 2 or 3) Patients who went on to receive neoadjuvant chemoradiotherapy. Anonymised scans Exclusion Criteria: MRIs from patients under the age of 18, or older than 99 years old will be excluded. MRIs from patients who did not receive neoadjuvant therapy for cancer will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer<br>Anonymised MRI scans (pre-therapy) of locally advanced breast cancer sufferers. | Device: DRS probe<br>* The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe<br>|
| Rectal Cancer<br>Anonymised MRI scans (pre-therapy) of locally advanced rectal cancer sufferers. | Device: DRS probe<br>* The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation correlation | Correlation of sensor oxygenation measurements as compared to gold-standard oxygenation measurements in phantom tissue models | During Intervention: The DRS probe (intervention) and reference (control) measurements will take place within one hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer