Evaluating In Vivo OCT Imaging for Periocular Basal Cell Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Maidstone & Tunbridge Wells NHS Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Henry Smith, Maidstone & Tunbridge Wells NHS Trust
ClinicalTrials.gov Identifier:
NCT01603810
First received: May 19, 2012
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

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 Intervention
Basal Cell Carcinoma
Other: OCT

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Maidstone & Tunbridge Wells NHS Trust:

Groups/Cohorts Assigned Interventions
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
Other: OCT
Optical coherence tomography of periocular basal cell carcinoma

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with periocular basal cell carcinoma

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603810

Locations
United Kingdom
Maidstone Hospital Not yet recruiting
Maidstone, Kent, United Kingdom, ME16 9QQ
Contact: Henry B Smith, FRCOphth    01622226255    hbs@doctors.net.uk   
Sponsors and Collaborators
Maidstone & Tunbridge Wells NHS Trust
Investigators
Principal Investigator: Henry B Smith, FRCOphth Maidstone & Tunbridge Wells NHS Trust
  More Information

No publications provided

Responsible Party: Henry Smith, Oculoplastics Fellow, Maidstone & Tunbridge Wells NHS Trust
ClinicalTrials.gov Identifier: NCT01603810     History of Changes
Other Study ID Numbers: MTW001
Study First Received: May 19, 2012
Last Updated: May 21, 2012
Health Authority: United Kingdom: Research Ethics Committee
United States: Federal Government

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

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

ClinicalTrials.gov processed this record on July 29, 2014