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Diagnosis of Non-Melanoma Skin Cancer With Optical Coherence Tomography

Phase 1/Phase 2
18 Years
Open (Enrolling)
Skin Neoplasms

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Trial Information

Diagnosis of Non-Melanoma Skin Cancer With Optical Coherence Tomography

Optimal management of skin malignancies relies on early and accurate diagnosis. The
reference standard in skin cancer is biopsy and histopathological assessment from a clinical
suspicious skin lesion. The clinical diagnosis of skin cancer has sensitivity ranging from
50% to 90 % and specificity around 70% to 80% depending on the population studied and the
experience of the clinician.

A rapid, non-invasive technique that could be used for characterization of skin lesions
prior to biopsy would be valuable. In some patients with multiple, recurrent skin tumours
the need for numerous biopsies in the same area is problematic, both cosmetically and
diagnostically, as the cancer can be hidden under scar tissue.

The biopsy has several weaknesses: The biopsy must be done exactly in the tumour, and it
does not delineate the tumour borders. Biopsy from skin is in general easy, but there are
problematic places such as the T-zone in the face, the eyelids and the ears. Notably these
places are areas where most types of skin cancer exhibit aggressive, invasive growth and
have a high recurrence rate.

OCT is a novel, non-invasive optical imaging technology. It can provide cross-sectional
tomographic images of tissue pathology in situ and in real time, without the need for
excision and processing of specimens, as in conventional histopathology. OCT uses harmless,
infrared light to create high-resolution images of tissue. OCT provides cross-sectional
images of structures below the tissue surface in analogy to histopathology. Hence OCT can
function as an “optical biopsy” providing images of tissue structure on the micron scale.
For example, OCT could be used where standard excisional biopsy is hazardous or impossible,
and OCT could reduce sampling errors associated with excisional biopsy.

Inclusion Criteria:

- Patients above the age of 18 years with primary non-melanoma skin cancer NMSC or
precancerous lesions from the Dermatology Department, and the Plastic Surgery
Department at Roskilde Hospital, and from office based dermatologist in Roskilde
County. Patients will only be recruited after informed consent.

Exclusion Criteria:

- Pregnancy.

- To avoid the potential bias of scar tissue in the OCT images we will not include OCT
images from recurrent NMSC in this study.

- Patients will be excluded from the study if they are not able to give an informed
consent. Staff from the Dermatology, Internal Medicine and Plastic Surgery
Departments at RAS cannot be included in the phase I/phase 2 study.

- Gender: both

- Age limits: 18- no max

Type of Study:


Study Design:

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional, Time Perspective: Prospective

Principal Investigator

Mette Mogensen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. of Dermatology, Roskilde Hospital


Denmark: The Danish National Committee on Biomedical Research Ethics

Study ID:




Start Date:

February 2006

Completion Date:

July 2008

Related Keywords:

  • Skin Neoplasms
  • Optical coherence tomography
  • Neoplasms
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Carcinoma, Basosquamous
  • Carcinoma, Squamous Cell