Accuracy of diagnosing skin cancers with non-invasive optical coherence tomography (OCT) and line-field confocal OCT (LC-OCT) imaging compared to skin biopsy
| ISRCTN | ISRCTN15698540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15698540 |
| Integrated Research Application System (IRAS) | 351678 |
| Sponsor | Barts Health NHS Trust |
| Funder | Barts Charity |
- Submission date
- 08/06/2026
- Registration date
- 26/08/2026
- Last edited
- 26/08/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
This study aims to investigate the clinical accuracy of two CE-marked non-invasive imaging devices: optical coherence tomography (OCT) and line confocal optical coherence tomography (LC-OCT) in the assessment of skin lesions and the extent to which it can be used to reduce the need for a diagnostic biopsy and its associated clinical and resource costs.
Who can participate?
Patients who have skin lesions planned for skin surgery at Dermatology Department, Royal London Hospital, Barts Health NHS Trust
What does the study involve?
Participants will follow their normal clinical and surgical pathway and those with relevant lesions will be scanned in advance of their procedure with OCT and LC-OCT. The histopathological diagnosis following their surgery will be compared to the diagnosis obtained by the imaging modalities. The comparison will allow us to understand the accuracy of the optical coherence tomography in assessing skin lesions and the extent to which this can be used to reduce the diagnostic need for an invasive skin biopsy and reduce time to diagnosis and treatment.
What are the possible benefits and risks of participating?
The benefits of participating include:
1. Faster diagnosis in the future, helping patients get results more quickly, possibly without the need of a skin biopsy
2. Fewer unnecessary biopsies, which means fewer invasive procedures and less discomfort
3. Better planning before surgery, including more accurate mapping of skin cancers, which can help with treatment decisions and reduce anxiety.
4. Shorter surgeries, particularly during procedures like Mohs surgery, making the experience more comfortable.
5. Improved diagnosis of skin cancer types, such as basal cell carcinoma (BCC), so that the most suitable treatment can be chosen.
6. Better monitoring of how well treatments work, especially for treatments that target the surface of the skin.
7. Improved ability to tell early cancers apart, such as identifying when a skin condition has started to become more serious.
8. Clearer distinction between harmless and harmful lesions, especially when the appearance of a skin lesion makes diagnosis difficult.
What are the possible disadvantages and risks of taking part?
There is no risk to your safety, as this study uses a non-invasive scanner. However, being part of this study may take a little more time during your clinic visit to complete the questionnaire and the scanning.
Where is the study run from?
Barts Health NHS Trust (UK)
When is the study starting and how long is it expected to run for?
May 2026 to May 2028
Who is funding the study?
Barts Charity (UK)
Who is the main contact?
Prof. Catherine Harwood, catherine.harwood1@nhs.net
Contact information
Scientific, Principal investigator
Department of Dermatology
Royal London Hospital
Whitechapel Road
London
E1 1FR
United Kingdom
 ORCID ID |
0000-0002-1375-0965 |
|---|---|
| Phone | +44 (0)7764947063 |
| catherine.harwood1@nhs.net |
Public
Department of Dermatology
Royal London Hospital
Whitechapel Road
London
E1 1FR
United Kingdom
| Phone | +44 (0)7764947063 |
|---|---|
| kb@dermatologist.london |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Non-randomised pilot feasibility cohort study |
| Secondary study design | Longitudinal study |
| Scientific title | Optical Coherence Tomography in OutPatient dermatology UnitS (OCTOPUS): a non-randomised pilot cohort study |
| Study acronym | OCTOPUS |
| Study objectives | This is a pilot study to establish the feasibility of performing a future phase III trial evaluating the non-inferiority of two CE-marked non-invasive imaging devices (optical coherence tomography, OCT; line confocal optical coherence tomography, LC-OCT) versus the gold standard of clinical assessment and skin biopsy with histopathology in the accurate and cost-effective diagnosis of skin lesions suspicious for skin cancer and precancer. |
| Ethics approval(s) |
Approved 27/01/2026, HRA and Health and Care Research Wales (HCRW) (Floor Four, North, Welsh Government Offices, Cathays Park, King Edward VII Avenue, Cardiff, CF10 3NQ, United Kingdom; -; approvals@hra.nhs.uk; HCRW.approvals@wales.nhs.uk), ref: 25/ES/0097 |
| Health condition(s) or problem(s) studied | Skin lesions suspicious for keratinocyte skin cancer and pre-cancer |
| Methodology | Scanning skin lesions using both optical coherence tomography (OCT) and line confocal optical coherence tomography (LC-OCT) prior to skin surgery, which is part of their standard care. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Interpretation of skin lesions based on scans using the OCT machine prior to skin biopsy made by dermatologists compared to the histological diagnosis obtained through skin biopsy at a single timepoint |
| Key secondary outcome measure(s) |
1. Patient acceptability, tolerability, and preference of using the OCT and LC-OCT are measured on a questionnaire at a single timepoint |
| Completion date | 18/05/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 105 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Participants with skin lesions requiring diagnostic biopsy or excision for diagnosis and referred by consultant dermatologists or specialist dermatology doctors. Lesions will include suspected keratinocyte skin cancer or pre-cancerous lesions, other skin cancers and pre-cancers, benign skin tumours, inflammatory skin conditions, infective disease) 2. Eligible participants will be identified from clinic and surgical lists from the dermatology clinics at Royal London Hospital 3. Adults over the age of 18 years 4. No restrictions on gender 5. Understand and willing to provide informed consent 6. No language restrictions – for those unable to speak English as part of the consent process interpreters who would be required for facilitating routine surgical consent will also be used for study consent |
| Key exclusion criteria | 1. Patients who are unwilling or unable to provide informed consent 2. No patients will be excluded based on gender, language, medical history |
| Date of first enrolment | 18/05/2026 |
| Date of final enrolment | 18/05/2028 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
80 Newark Street
London
E1 2ES
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
29/06/2026: Study's existence confirmed by the East of Scotland Research Ethics Service (EoSRES).
