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Investigation of the Vivosight system for diagnosis and assistance in the management of cutaneous basal cell carcinoma (BCC)

In the diagnosis of cutaneous BCC, how does the specificity and sensitivity of the Vivosight system compare to skin biopsy in differentiating subtypes.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12614000751673
Enrollment
168
Registered
2014-07-16
Start date
2014-03-27
Completion date
2015-03-26
Last updated
2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to collect information on the ability of the Vivosight OCT system to distinguish basal cell carcinomas that require surgical treatment from those that would respond to non- invasive therapy based on lesion depth. In the future this might allow the clinician to select the appropriate treatment course without requiring a biopsy to determine how deep the lesion is, preventing possible recurrence in the cases where the lesion is deeper than anticipated. Who is it for? All patients with pink patches suspicious for superficial BCC will be recruited into the study at their first visit. Study details During the patient’s first visit, a clinical photograph, and dermoscopy photograph of the lesions will be taken. The OCT scan will also be taken, which is a non-invasive, optical imaging technique, lasting less than 1 minute. A skin biopsy will then be taken to confirm the diagnosis. With the results from the skin biopsy, patients will be advised on treatment option. If patient has a superficial BCC, the treatment will be topical and these patients will be followed up in 6 months. If patients do not have superficial BCC, they will be advised on appropriate treatment option, but will not be required to have 6 months follow up. At 6 months, all superficial BCC cases will be followed up with clinical photograph, dermoscopy photograph of the treated lesion. The OCT scan and skin biopsy will be taken again to determine the clearance of the treated BCC. Based on the skin biopsy results, further treatment advice will be given. This will not be part of the protocol and is based on best clinical practice.

Interventions

Vivosight optical coherence tomography is a type of optical scanner that provides high resolution pictures of the superficial tissue by using very low intensity laser beams without causing any injury or having to cut out the tissue. The scan will be taken twice during the research, once at the baseline visit, and once at 6 month follow up. The scan itself will not take more than 1 minute and will not influence the treatment. If patient has a superficial BCC based on biopsy, the treatment will be

Vivosight optical coherence tomography is a type of optical scanner that provides high resolution pictures of the superficial tissue by using very low intensity laser beams without causing any injury or having to cut out the tissue. The scan will be taken twice during the research, once at the baseline visit, and once at 6 month follow up. The scan itself will not take more than 1 minute and will not influence the treatment. If patient has a superficial BCC based on biopsy, the treatment will be topical and these patients will be followed up in 6 months. If patients do not have superficial BCC based on biopsy, they will be advised on appropriate treatment option, but will not be required to have 6 months follow up.

Sponsors

Melanoma Institute of Australia
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients must be aged 18 years or older; present with pink patch lesions that are suspected superficial basal cell carcinomas; be able to follow trial instructions; and be likely to complete all trial requirements (must be willing to give written informed consent and to allow photographs and images of the selected treatment area).

Exclusion criteria

Patients unable to give consent or follow trial instructions.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026