Development and Validation of a Tumour Oxygenation Monitoring Probe

Cancer Clinical Trial

Official title:

Development and Validation of a Tumour Oxygenation Monitoring Probe

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03982355
• Other study ID #: 19SM5221
• Status: Recruiting
• Start date: August 9, 2019
• Est. completion date: June 2020

Study information

• Verified date: August 2019
• Source: Imperial College London
• Contact: Simon D Dryden, MBChB, MPH
• Phone: 447828464949
• Email: simon.dryden[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Device:
• DRS probe
The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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