Development and Validation of a Tumour Oxygenation Monitoring Probe

NCT ID: NCT03982355

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-09
• Study Completion Date: 2020-06-30

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.

Conditions

Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Breast Cancer

Anonymised MRI scans (pre-therapy) of locally advanced breast cancer sufferers.

DRS probe

Intervention Type: DEVICE

The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe

Rectal Cancer

Anonymised MRI scans (pre-therapy) of locally advanced rectal cancer sufferers.

DRS probe

Intervention Type: DEVICE

The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe

Interventions

DRS probe

The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ara Darzi

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Imperial College London

London, Greater London, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19SM5221

Identifier Type: -

Identifier Source: org_study_id