NCT01603810

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2012

Completed
Last Updated

May 22, 2012

Status Verified

May 1, 2012

First QC Date

May 19, 2012

Last Update Submit

May 21, 2012

Conditions

Keywords

Basal cell carcinomaOptical Coherence Tomography

Study Arms (1)

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

Interventions

OCTOTHER

Optical coherence tomography of periocular basal cell carcinoma

BCC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with periocular basal cell carcinoma

You may qualify if:

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

You may not qualify if:

  • Children, vulnerable adults, inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maidstone Hospital

Maidstone, Kent, ME16 9QQ, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Study Officials

  • Henry B Smith, FRCOphth

    Maidstone & Tunbridge Wells NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oculoplastics Fellow

Study Record Dates

First Submitted

May 19, 2012

First Posted

May 22, 2012

Last Updated

May 22, 2012

Record last verified: 2012-05

Locations