Cancer
Conditions
Keywords
Cancer
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.
Interventions
DEVICEDRS probe
The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe
Sponsors
Imperial College London
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Participant flow
Pre-assignment details
20 anonymised MRI scans, including 10 each from the breast and rectal cancer groups. The inclusion and exclusion criteria are provided to a member of the radiology team who selected the appropriate cases, anonymised the MRIs and provided all 20 DICOM files. All cases were therefore appropriate for inclusion from the outset, and therefore there was other significant events.
Participants by arm
| Arm | Count |
|---|---|
| Breast Cancer Anonymised MRI scans (pre-therapy) of locally advanced breast cancer sufferers.
DRS probe: The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe | 10 |
| Breast Cancer Anonymised MRI scans (pre-therapy) of locally advanced breast cancer sufferers.
DRS probe: The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe | 10 |
| Rectal Cancer Anonymised MRI scans (pre-therapy) of locally advanced rectal cancer sufferers.
DRS probe: The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe | 10 |
| Rectal Cancer Anonymised MRI scans (pre-therapy) of locally advanced rectal cancer sufferers.
DRS probe: The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe | 10 |
| Total | 40 |
Baseline characteristics
| Characteristic | Rectal Cancer | Total | Breast Cancer |
|---|---|---|---|
| Age, Continuous | NA years | NA years | NA years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 10 participants | 20 participants | 10 participants |
| Sex/Gender, Customized NA | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Count of MRIs Successfully Modelled for Oxygen Correlation
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
Time frame: MRIs were 3D modelled - single time point at time of MRI
Population: Scans analysed and segmented to guide the development of the DRS probe
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Breast Cancer (10) | Count of MRIs Successfully Modelled for Oxygen Correlation | 10 MRIs analyses |
| Rectal Cancer (10) | Count of MRIs Successfully Modelled for Oxygen Correlation | 10 MRIs analyses |