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Completed

NCT Number: NCT03982355

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.

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College London

London, Greater London, W21NY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DRS probe

Device

The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe

Primary outcomes

  1. Count of MRIs Successfully Modelled for Oxygen Correlation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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