Using a new non-invasive imaging technique to assess oral pre-cancer and mouth cancer
| ISRCTN | ISRCTN16190792 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16190792 |
| Sponsor | University of Dundee |
| Funder | Tay Health Tech |
- Submission date
- 09/07/2026
- Registration date
- 28/09/2026
- Last edited
- 28/09/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Some conditions in the mouth can develop into mouth cancer if they are not detected and managed early. At present, diagnosis mainly relies on clinical examination and biopsy, which can be invasive and uncomfortable. This study aims to investigate whether a new, non-invasive imaging technique called optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) can provide detailed images of the mouth lining and its blood vessels to support future diagnosis and monitoring of oral pre-cancer and mouth cancer.
Who can participate?
Adults aged 18 years or over who have suspected or confirmed oral pre-cancer (oral potentially malignant disorders) or mouth cancer
What does the study involve?
Participants will attend one study visit during their routine outpatient appointment. After providing informed consent, they will undergo a non-invasive OCT/OCTA scan of the oral lesion and, where appropriate, nearby normal tissue. The scan takes approximately 20–30 minutes, and participants will also be asked to complete a short questionnaire about their experience.
What are the possible benefits and risks of participating?
Participants are unlikely to receive a direct medical benefit from taking part. However, the study may help develop improved, non-invasive methods for assessing oral diseases in the future. The imaging procedure is non-invasive and considered low risk. Some participants may experience minor discomfort from holding the imaging probe inside the mouth during scanning.
Where is the study run from?
University of Dundee Dental Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2026 to September 2027
Who is funding the study?
Tay Health Tech
Who is the main contact?
Dr Chunhui Li, c.li@dundee.ac.uk
Contact information
Principal investigator, Public, Scientific
G8 Fulton Building, University of Dundee
Dundee
DD14HN
United Kingdom
| Phone | +44 (0)1382386730 |
|---|---|
| c.li@dundee.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Device feasibility, Diagnostic, Prevention, Screening |
| Scientific title | Optical coherence tomography and angiography imaging of oral mucosa in patients with oral potentially malignant disorders and oral cancer |
| Study acronym | OROCTA |
| Study objectives | The primary objective of this study is to evaluate the feasibility and acceptability of optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) for imaging oral potentially malignant disorders (OPMDs) and oral squamous cell carcinoma (OSCC). Secondary objectives are to assess image quality and explore structural and vascular imaging biomarkers that may support the future development of non-invasive diagnostic tools for oral cancer. |
| Ethics approval(s) |
Not yet submitted |
| Health condition(s) or problem(s) studied | Oral potentially malignant disorders (OPMDs) or oral squamous cell carcinoma (OSCC) |
| Intervention | Participants will attend a single study visit during a routine outpatient appointment. Following informed consent, they will undergo non-invasive intraoral optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) imaging of clinically suspicious oral lesions and, where feasible, adjacent normal mucosa. Up to three scans will be acquired at each imaging site to optimise image quality and assess reproducibility. Participants will also complete a brief acceptability questionnaire after imaging. The imaging procedure will not alter routine clinical management, and no additional treatment will be provided as part of the study. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Custom-built swept-source optical coherence tomography (SS-OCT) and optical coherence tomography angiography (OCTA) system |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 30/09/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Patients with clinically suspected or histologically confirmed oral potentially malignant disorders (OPMDs) and/or oral squamous cell carcinoma (OSCC) 2. Adults aged 18 years or older 3. Able and willing to provide written informed consent 4. Patients with clinically suspected or histologically confirmed oral potentially malignant disorders (OPMDs) or oral squamous cell carcinoma (OSCC) 5. Able to tolerate intraoral OCT/OCTA imaging during a single study visit |
| Key exclusion criteria | 1. Unable or unwilling to provide written informed consent 2. Unable to tolerate intraoral OCT/OCTA imaging (e.g., severe trismus or inability to maintain the required position) 3. Currently participating in the interventional phase of another clinical trial 4. Any medical condition that, in the opinion of the investigator, would compromise participant safety or study integrity |
| Date of first enrolment | 01/10/2026 |
| Date of final enrolment | 01/09/2027 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Dundee
DD1 4HN
Scotland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
27/08/2026: Study's existence confirmed by the University of Dundee.
