Trial Outcomes & Findings for Development and Validation of a Tumour Oxygenation Monitoring Probe (NCT NCT03982355)
NCT ID: NCT03982355
Last Updated: 2024-09-19
Results Overview
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
COMPLETED
20 participants
MRIs were 3D modelled - single time point at time of MRI
2024-09-19
Participant Flow
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.
Unit of analysis: MRIs analyses
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
10 10
|
10 10
|
|
Overall Study
COMPLETED
|
10 10
|
10 10
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Breast Cancer
n=10 MRIs
Anonymised MRI scans (pre-therapy) of locally advanced breast cancer sufferers.
DRS probe: The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe
|
Rectal Cancer
n=10 MRIs
Anonymised MRI scans (pre-therapy) of locally advanced rectal cancer sufferers.
DRS probe: The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe
|
Total
n=20 MRIs
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
NA years
STANDARD_DEVIATION NA • n=10 Participants
|
NA years
STANDARD_DEVIATION NA • n=10 Participants
|
NA years
STANDARD_DEVIATION NA • n=20 Participants
|
|
Sex/Gender, Customized
NA
|
NA Participants
n=10 Participants
|
NA Participants
n=10 Participants
|
NA Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: MRIs were 3D modelled - single time point at time of MRIPopulation: Scans analysed and segmented to guide the development of the DRS probe
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
Outcome measures
| Measure |
Breast Cancer (10)
n=10 MRIs analyses
Anonymised MRI scans (pre-therapy) of locally advanced breast cancer sufferers.
DRS probe: The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe
|
Rectal Cancer (10)
n=10 MRIs analyses
Anonymised MRI scans (pre-therapy) of locally advanced rectal cancer sufferers.
DRS probe: The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe
|
|---|---|---|
|
Count of MRIs Successfully Modelled for Oxygen Correlation
|
10 MRIs analyses
|
10 MRIs analyses
|
Adverse Events
Breast Cancer (10)
Rectal Cancer (10)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place