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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer | Anonymised MRI scans (pre-therapy) of locally advanced breast cancer sufferers. |
| |
| Rectal Cancer | Anonymised MRI scans (pre-therapy) of locally advanced rectal cancer sufferers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DRS probe | Device | The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | MRIs were 3D modelled - single time point at time of MRI |
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Inclusion Criteria:
Exclusion Criteria:
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Pretreatment anonymised MRIs from (locally advanced) breast and rectal cancer sufferers
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| Name | Affiliation | Role |
|---|---|---|
| Ara Darzi | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London | London | Greater London | W21NY | United Kingdom |
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.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Breast Cancer (10) | Anonymised MRI scans (pre-therapy) of locally advanced breast cancer sufferers. DRS probe: The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe |
| FG001 | Rectal Cancer (10) | Anonymised MRI scans (pre-therapy) of locally advanced rectal cancer sufferers. DRS probe: The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
10 each of MRI scans from patients with locally advanced breast and rectal cancer. The MRIs were anonymised, and as such no population information is available
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Rectal Cancer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Scans analysed and segmented to guide the development of the DRS probe | Posted | Count of Units | MRIs analyses | MRIs were 3D modelled - single time point at time of MRI | MRIs analyses | MRIs analyses |
|
Not collected. The anonymised MRIs of patients were used. The patients themselves were never included in the study and so not at risk
Only MRIs used, bot patients. Therefore no risk to patients of adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Breast Cancer (10) | Anonymised MRI scans (pre-therapy) of locally advanced breast cancer sufferers. DRS probe: The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr SImon Dryden | IMperial COllege London | +447828464949 | simon.dryden@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2019 | Apr 26, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Anonymised MRI scans (pre-therapy) of locally advanced rectal cancer sufferers.
DRS probe: The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe
| BG002 | Total | Total of all reporting groups |
| MRIs |
|
| years |
| Participants |
|
|
| Sex/Gender, Customized | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Number | participants | Participants |
|
|
Anonymised MRI scans (pre-therapy) of locally advanced rectal cancer sufferers. DRS probe: The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Rectal Cancer (10) | Anonymised MRI scans (pre-therapy) of locally advanced rectal cancer sufferers. DRS probe: The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe | 0 | 0 | 0 | 0 | 0 | 0 |
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