Development and Validation of a Tumour Oxygenation Monitoring Probe

• Conditions: Cancer
• Interventions: Device: DRS probe

• Registration Number: NCT03982355
• Lead Sponsor: Imperial College London

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-06-10
• Study First Posted: 2019-06-11
• Status Verified: 2019-08
• Study Start: 2019-08-09
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-15
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rectal Cancer	DRS probe	Anonymised MRI scans (pre-therapy) of locally advanced rectal cancer sufferers.
Breast Cancer	DRS probe	Anonymised MRI scans (pre-therapy) of locally advanced breast cancer sufferers.

Primary Outcome Measures

Name	Time	Method
Count of MRIs Successfully Modelled for Oxygen Correlation	MRIs were 3D modelled - single time point at time of MRI	Number of MRIs 3D modelled for oxygenation sensor development; Note: this outcome measure was orginally expressed as "Oxygenation Correlation" though this was modeled and therefore we have expressed it as above

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, Greater London, United Kingdom