Evaluating In Vivo OCT Imaging for Periocular Basal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01603810
Recruitment Status : Unknown
Verified May 2012 by Henry Smith, Maidstone & Tunbridge Wells NHS Trust.
Recruitment status was:  Not yet recruiting
First Posted : May 22, 2012
Last Update Posted : May 22, 2012
Information provided by (Responsible Party):
Henry Smith, Maidstone & Tunbridge Wells NHS Trust

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.

Condition or disease Intervention/treatment
Basal Cell Carcinoma Other: OCT

Study Type : Observational
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Investigation of the Correlation Between OCT and Histology in Defining the Margins of Periocular Basal Cell Carcinoma

Group/Cohort Intervention/treatment
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
Other: OCT
Optical coherence tomography of periocular basal cell carcinoma

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with periocular basal cell carcinoma

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01603810

United Kingdom
Maidstone Hospital Not yet recruiting
Maidstone, Kent, United Kingdom, ME16 9QQ
Contact: Henry B Smith, FRCOphth    01622226255   
Sponsors and Collaborators
Maidstone & Tunbridge Wells NHS Trust
Principal Investigator: Henry B Smith, FRCOphth Maidstone & Tunbridge Wells NHS Trust

Responsible Party: Henry Smith, Oculoplastics Fellow, Maidstone & Tunbridge Wells NHS Trust Identifier: NCT01603810     History of Changes
Other Study ID Numbers: MTW001
First Posted: May 22, 2012    Key Record Dates
Last Update Posted: May 22, 2012
Last Verified: May 2012

Keywords provided by Henry Smith, Maidstone & Tunbridge Wells NHS Trust:
Basal cell carcinoma
Optical Coherence Tomography

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell