CancerNCT03982355
Development and Validation of a Tumour Oxygenation Monitoring Probe
An observational study of Cancer, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cancer
- What is being tested?
- DRS probe
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Aug 2019to 30 Jun 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pretreatment anonymised MRIs from (locally advanced) breast and rectal cancer sufferers
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College London
London, Greater London, W21NY
About this study
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.
Read the 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
- Being tested
- DRS probe
- Keywords
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRS probeDevice
The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer | Anonymised MRI scans (pre-therapy) of locally advanced breast cancer sufferers. Receives: Device: DRS probe | |
| Rectal Cancer | Anonymised MRI scans (pre-therapy) of locally advanced rectal cancer sufferers. Receives: Device: DRS probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: MRIs were 3D modelled - single time point at time of MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start9 Aug 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ara Darzi, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982355
- Sponsor's protocol ID
- 19SM5221
- Status last verified
- Apr 2024
- First submitted
- 22 May 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Tumour Oxygenation Monitoring Probe
- ClinicalTrials.gov ID
- NCT03982355
- Acronym / sponsor ID
- 19SM5221
- Conditions
- Cancer
- Keywords
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer | – | Device: DRS probeAnonymised MRI scans (pre-therapy) of locally advanced breast cancer sufferers. |
| Rectal Cancer | – | Device: DRS probeAnonymised MRI scans (pre-therapy) of locally advanced rectal cancer sufferers. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pretreatment anonymised MRIs from (locally advanced) breast and rectal cancer sufferers
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DRS probeThe Oxygenation measurements of the novel diffuse reflectance spectroscopy probe | Device | Breast Cancer, Rectal Cancer |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ara Darzi principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of MRIs Successfully Modelled for Oxygen Correlation (time frame: MRIs were 3D modelled - single time point at time of MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.