Colonic PolypOPTICNCT03139942
Optical Polyp Testing for In Vivo Classification
A study testing Optical spectral reflectance and autofluorescence imaging in people with Colonic Polyp and Colonic Diseases, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Small growths detected in the colon (polyps) during a colonoscopy may or may not have the potential to develop into cancer. However, since visual inspection alone cannot separate all potentially harmful polyps from harmless ones, the standard approach is to remove them all for histological lab examination, exposing… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyp, Colonic Diseases, Colonic Neoplasms
- What is being tested?
- Optical spectral reflectance and autofluorescence imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Mar 2017to 11 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients attending for screening colonoscopy, urgent colonoscopy for altered bowel habit (on a two week wait) or those patients attending for polyp surveillance or therapy.
Who cannot join
- Patients with colitis, familial adenomatous polyposis or those that have undergone previous surgery as these different pathologies may confound interpretation of the optical signals.
- At the discretion of the endoscopist patients with poor bowel preparation will be excluded if it is judged that the colonoscopy cannot be completed. Further quality measures will be determined for reliable data acquisition (see outcome measures).
- Patients with acute gastrointestinal bleeding
- Patients with chronic liver disease
- Patients with abnormal coagulation or any other contra-indication to use of standard biopsy in routine diagnostic endoscopic procedures
- Patients who are unable or unwilling to give informed consent
- Patients under the age of 18 years
- Patients unable to speak English
Trial locations and contacts
1 site in 1 country.
About this study
Small growths detected in the colon (polyps) during a colonoscopy may or may not have the potential to develop into cancer. However, since visual inspection alone cannot separate all potentially harmful polyps from harmless ones, the standard approach is to remove them all for histological lab examination, exposing patients to risk of injury and putting a significant demand on hospital resources. An accurate method of determining polyp type during endoscopy would enable the clinician to only remove potentially harmful polyps. A new endoscopic optical imaging probe (OPTIC), which analyses how light interacts with tissue, is proposed to do this. The probe is contained within a normal endoscope and uses white light and blue/violet laser light to illuminate the tissue. The reflected and fluorescent light emitted, along with normal colour pictures of the polyp surface, are measured and recorded to quantify specific characteristics of each type. Optical measurements of polyps detected in endoscopy clinics at Imperial College Healthcare NHS Trust will be analysed to determine if the signal can be used to differentiate different polyp types.
Read the detailed description
Polyps detected during a colonoscopy may range from benign to precancerous and cancerous. While experienced endoscopists can reliably recognise cancer, the difference between small polyps that have the potential to develop into cancer (adenomas) and those that do not (hyperplastic), is often ambiguous. The standard approach is to simply remove all polyps and analyse them in the histology lab. This means that many patients with hyperplastic polyps (40% of those detected) are unnecessarily exposed to risk of injury (bowel perforation and bleeding) during removal. Furthermore the NHS faces the significant cost of diagnosing this harmless colon tissue. If clinicians were able to accurately determine polyp type during endoscopy, without removal, then hyperplastic tissue could be left alone while potentially harmful tissue is removed.
A pilot study of a new endoscopic optical imaging probe (OPTIC), which analyses how different colours of light interact with tissue, is proposed. Previous research has indicated that these properties differ in hyperplastic and adenomatous polyps. The probe is contained within a normal endoscope and uses white light and blue/violet laser light to illuminate the tissue. The reflected and fluorescent light emitted, along with normal colour pictures of the polyp surface, are measured and recorded to quantify specific characteristics of each type.
Patients attending endoscopy clinics at Imperial College Healthcare NHS Trust will be asked to allow the use of the OPTIC probe during their colonoscopy. If the clinician detects a polyp that he/she intends to remove then this will be analysed using OPTIC before removal. The histology results from the tissue sample will be recorded and correlated to the OPTIC probe measurements. The resulting library of optical data will be used to design software to automatically categorise unknown polyps based on the OPTIC signal. The accuracy of the technique will be compared to the clinicians' visual assessments. The patients' involvement in the study ceases after the colonoscopy.
- Conditions
- Colonic Polyp, Colonic Diseases, Colonic Neoplasms, Colonic Adenoma, Colonic Adenocarcinoma, Colonic Dysplasia
- Being tested
- Optical spectral reflectance and autofluorescence imaging
- Keywords
- Endoscopy, Colonoscopy, Hyperspectral imaging, Tissue classification, Tissue autofluorescence, Advanced imaging techniques
- Medical subject headings
- Colonic Polyps, Colonic Diseases, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical spectral reflectance and autofluorescence imagingDevice
When a suitable area of tissue is identified by the clinician during a patient's colonoscopy (e.g., a polyp), the imaging probe is inserted into the colonoscope so that it can view the tissue. Optical spectral reflectance and autofluorescence imaging is then performed to collect white light reflected by, and fluorescent light emitted from, the tissue. This is then analysed by hardware and software components in the external analysis unit.
| Study group | Role | What they receive |
|---|---|---|
| Imaging using OPTIC probe | Experimental | Single arm study to test the feasibility of a new device - the OPTIC imaging probe. All participants enrolled in the study may be imaged using optical spectral reflectance and autofluorescence imaging during their endoscopy procedure. Receives: Device: Optical spectral reflectance and autofluorescence imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of hyperplastic vs adenoma classification
Correlation of optical signals from colonic polyps and their histologically-confirmed diagnosis. Quantification of sensitivity, specificity, negative predictive value.
Measured: 1-2 weeks (from day of endoscopy and optical measurement, to return of histology results for any detected polyp)
Secondary outcomes (3)
Extension of classification algorithm to other polyp types (higher grade adenomas and cancer)
Sensitivity and specificity of measured optical signals in differentiating different grades of adenoma.
Measured: 1-2 weeks (from day of endoscopy and optical measurement, to return of histology results for any detected polyp)
Bowel preparation quality
Is bowel preparation quality sufficient for endoscopy to proceed? Bowel preparation for some patients may be imperfect and hamper collection of optical data. A measure of the quality and hence, reliability, of the measured data must be obtained for future reference in order to prevent erroneous readings.
Measured: 1 day (has bowel preparation been sufficient on day of endoscopy and optical measurement)
Mean time added to endoscopy due to additional imaging
An estimate of the time added to an endoscopic examination of the colon due to the need to insert and remove the OPTIC probe
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start14 Mar 2017
- Primary completion11 Jul 2017
- Study completion11 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julian P Teare, MD FRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139942
- Sponsor's protocol ID
- IRAS186652
- Acronym
- OPTIC
- Status last verified
- Apr 2019
- First submitted
- 24 Apr 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only anonymised data will be shared. The research team may share findings from the study with non-Imperial College academic collaborators, who will further develop aspects of its imaging capabilities.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Polyp Testing for In Vivo Classification
- ClinicalTrials.gov ID
- NCT03139942
- Acronym / sponsor ID
- OPTIC / IRAS186652
- Conditions
- Colonic Polyp, Colonic Diseases, Colonic Neoplasms, Colonic Adenoma, Colonic Adenocarcinoma, Colonic Dysplasia
- Keywords
- Endoscopy, Colonoscopy, Hyperspectral imaging, Tissue classification, Tissue autofluorescence, Advanced imaging techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 11 Jul 2017 (actual)
- Study completion
- 11 Jul 2017 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Small growths detected in the colon (polyps) during a colonoscopy may or may not have the potential to develop into cancer. However, since visual inspection alone cannot separate all potentially harmful polyps from harmless ones, the standard approach is to remove them all for histological lab examination, exposing patients to risk of injury and putting a significant demand on hospital resources. An accurate method of determining polyp type during endoscopy would enable the clinician to only remove potentially harmful polyps. A new endoscopic optical imaging probe (OPTIC), which analyses how light interacts with tissue, is proposed to do this. The probe is contained within a normal endoscope and uses white light and blue/violet laser light to illuminate the tissue. The reflected and fluorescent light emitted, along with normal colour pictures of the polyp surface, are measured and recorded to quantify specific characteristics of each type. Optical measurements of polyps detected in endoscopy clinics at Imperial College Healthcare NHS Trust will be analysed to determine if the signal can be used to differentiate different polyp types.
Detailed description
Polyps detected during a colonoscopy may range from benign to precancerous and cancerous. While experienced endoscopists can reliably recognise cancer, the difference between small polyps that have the potential to develop into cancer (adenomas) and those that do not (hyperplastic), is often ambiguous. The standard approach is to simply remove all polyps and analyse them in the histology lab. This means that many patients with hyperplastic polyps (40% of those detected) are unnecessarily exposed to risk of injury (bowel perforation and bleeding) during removal. Furthermore the NHS faces the significant cost of diagnosing this harmless colon tissue. If clinicians were able to accurately determine polyp type during endoscopy, without removal, then hyperplastic tissue could be left alone while potentially harmful tissue is removed.
A pilot study of a new endoscopic optical imaging probe (OPTIC), which analyses how different colours of light interact with tissue, is proposed. Previous research has indicated that these properties differ in hyperplastic and adenomatous polyps. The probe is contained within a normal endoscope and uses white light and blue/violet laser light to illuminate the tissue. The reflected and fluorescent light emitted, along with normal colour pictures of the polyp surface, are measured and recorded to quantify specific characteristics of each type.
Patients attending endoscopy clinics at Imperial College Healthcare NHS Trust will be asked to allow the use of the OPTIC probe during their colonoscopy. If the clinician detects a polyp that he/she intends to remove then this will be analysed using OPTIC before removal. The histology results from the tissue sample will be recorded and correlated to the OPTIC probe measurements. The resulting library of optical data will be used to design software to automatically categorise unknown polyps based on the OPTIC signal. The accuracy of the technique will be compared to the clinicians' visual assessments. The patients' involvement in the study ceases after the colonoscopy.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging using OPTIC probe | Experimental | Device: Optical spectral reflectance and autofluorescence imagingSingle arm study to test the feasibility of a new device - the OPTIC imaging probe. All participants enrolled in the study may be imaged using optical spectral reflectance and autofluorescence imaging during their endoscopy procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients attending for screening colonoscopy, urgent colonoscopy for altered bowel habit (on a two week wait) or those patients attending for polyp surveillance or therapy.
Key exclusion criteria (8 listed)
- Patients with colitis, familial adenomatous polyposis or those that have undergone previous surgery as these different pathologies may confound interpretation of the optical signals.
- At the discretion of the endoscopist patients with poor bowel preparation will be excluded if it is judged that the colonoscopy cannot be completed. Further quality measures will be determined for reliable data acquisition (see outcome measures).
- Patients with acute gastrointestinal bleeding
- Patients with chronic liver disease
- Patients with abnormal coagulation or any other contra-indication to use of standard biopsy in routine diagnostic endoscopic procedures
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 |
|---|---|---|
| Optical spectral reflectance and autofluorescence imagingWhen a suitable area of tissue is identified by the clinician during a patient's colonoscopy (e.g., a polyp), the imaging probe is inserted into the colonoscope so that it can view the tissue. Optical spectral reflectance and autofluorescence imaging is then performed to collect white light reflected by, and fluorescent light emitted from, the tissue. This is then analysed by hardware and software components in the external analysis unit. | Device | Imaging using OPTIC probe |
Primary outcome
Diagnostic accuracy of hyperplastic vs adenoma classification
Time frame: 1-2 weeks (from day of endoscopy and optical measurement, to return of histology results for any detected polyp)
Correlation of optical signals from colonic polyps and their histologically-confirmed diagnosis. Quantification of sensitivity, specificity, negative predictive value.
3 secondary outcomes
Extension of classification algorithm to other polyp types (higher grade adenomas and cancer)
Time frame: 1-2 weeks (from day of endoscopy and optical measurement, to return of histology results for any detected polyp)
Bowel preparation quality
Time frame: 1 day (has bowel preparation been sufficient on day of endoscopy and optical measurement)
Mean time added to endoscopy due to additional imaging
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: Undecided. Only anonymised data will be shared. The research team may share findings from the study with non-Imperial College academic collaborators, who will further develop aspects of its imaging capabilities.
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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.
Julian P Teare, MD FRCP 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?
A study testing Optical spectral reflectance and autofluorescence imaging in people with Colonic Polyp and Colonic Diseases, 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 1 inclusion and 8 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 16 Apr 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic accuracy of hyperplastic vs adenoma classification (time frame: 1-2 weeks (from day of endoscopy and optical measurement, to return of histology results for any detected polyp)). 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 16 Apr 2019.