Evaluating In Vivo OCT Imaging for Periocular Basal Cell Carcinoma

NCT ID: NCT01603810

Last Updated: 2012-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Study Classification: OBSERVATIONAL

Brief Summary

Optical coherence tomography (OCT) is an imaging technique which shows the internal structure of living tissue (in vivo). It is safe, quick and painless to perform, and does not damage the tissue in any way. Recent advances in the technology mean that it can now be used to take images of the internal structure of the skin. This is useful because certain conditions, such as skin cancers, alter this structure. At present a suspected skin cancer is identified by taking a sample (a biopsy) which is analysed under the microscope to confirm the diagnosis. The cancer is then excised including a margin of apparently healthy-looking skin around it to ensure that the entirety of the tumour is removed. The excised tumour is then analysed again under a microscope to confirm that it was indeed completely removed (histology), after which a further operation is required to repair the defect.

The purpose of this study is to evaluate OCT imaging of a particular type of skin cancer called a basal cell carcinoma (BCC), and in particular BCCs affecting the skin around the eyes (periocular). The study will compare the ability of OCT to define the margin of the BCC with the current 'gold standard' of histology. OCT could potentially improve the investigators ability to define the margins of the tumour before surgery and become a guide for minimally invasive surgery. The preservation of healthy tissue represents a priority, particularly in the area of the skin surrounding the eye.

Conditions

Basal Cell Carcinoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

BCC

Adult of any age or gender with capacity to give informed consent who has a basal cell carinoma requiring surgical excision and involving the periocular skin

OCT

Intervention Type: OTHER

Optical coherence tomography of periocular basal cell carcinoma

Interventions

OCT

Optical coherence tomography of periocular basal cell carcinoma

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults of any age or gender who have capacity to give informed consent, and who have periocular basal cell carcinoma requiring surgical excision

Exclusion Criteria

• Children, vulnerable adults, inability to give informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maidstone & Tunbridge Wells NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Henry Smith

Oculoplastics Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henry B Smith, FRCOphth

Role: PRINCIPAL_INVESTIGATOR

Maidstone & Tunbridge Wells NHS Trust

Locations

Maidstone Hospital

Maidstone, Kent, United Kingdom

Countries

United Kingdom

Facility Contacts

Henry B Smith, FRCOphth

Role: primary

hbs@doctors.net.uk

01622226255

Other Identifiers

MTW001

Identifier Type: -

Identifier Source: org_study_id