Development and Validation of a Tumour Oxygenation Monitoring Probe

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.

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Device: DRS probe

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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Simon D Dryden, MBChB, MPH; Phone Number: 447828464949; Email: simon.dryden@imperial.ac.uk

Study Locations

• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, W21NY
      • Recruiting
      • Imperial College London
      • Contact: Simon D Dryden, MBChB, MPH; Phone Number: 447828464949; Email: simon.dryden@imperial.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pretreatment anonymised MRIs from (locally advanced) breast and rectal cancer sufferers

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breast Cancer; Anonymised MRI scans (pre-therapy) of locally advanced breast cancer sufferers.	Device: DRS probe; The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe
Rectal Cancer; Anonymised MRI scans (pre-therapy) of locally advanced rectal cancer sufferers.	Device: DRS probe; The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Cancer
• Other Study ID Numbers: 19SM5221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The anonymised scans will be used for this study alone. The participant identifiable data will not be available to our research team, and the scan data will not be made available outside of the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No