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Investigate the Diagnostic Value and Possibilities of OCT in Non-Melanoma Skin Cancer.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2006 by Zealand University Hospital.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: October 19, 2006
Last Update Posted: October 19, 2006
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.
Information provided by:
Zealand University Hospital
We will do systematic and functional assessment of non-melanoma skin cancer including precancerous lesions by OCT imaging and other diagnostic methods. The systematic assessment will be comparison of clinical diagnosis, histopathology, OCT images, spectrophotometry and high frequency ultrasound of non-melanoma skin cancer Functional exploration of non-melanoma skin cancer is done with Doppler-OCT and polarization-sensitive-OCT.

Condition Intervention Phase
Skin Neoplasms Device: optical coherence tomography Phase 1 Phase 2

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Diagnosis of Non-Melanoma Skin Cancer With Optical Coherence Tomography

Resource links provided by NLM:

Further study details as provided by Zealand University Hospital:

Estimated Enrollment: 120
Study Start Date: February 2006
Estimated Study Completion Date: July 2008
Detailed Description:

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00390351

Contact: Mette Mogensen, MD +45 4732 2116 rsmmog@ra.dk
Contact: Gregor BE Jemec, MD, DMSc +45 4732 2022 rsgrj@ra.dk

Dept. of Dermatology, Copenhagen University Suspended
DK-4000 Roskilde, Denmark, 4000
Roskilde Hospital Recruiting
Roskilde, Denmark, DK-4000
Contact: Mette Mogensen, MD    +45 4732 2116    rsmmog@ra.dk   
Contact: Gregor BE Jemec, MD, DMSc    +45 4732 2022    rsgrj@ra.dk   
Principal Investigator: Mette Mogensen, MD         
Sponsors and Collaborators
Zealand University Hospital
Principal Investigator: Mette Mogensen, MD Dept. of Dermatology, Roskilde Hospital
Study Director: Gregor BE Jemec, MD, DMSc Dept. of Dermatology, Roskilde Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00390351     History of Changes
Other Study ID Numbers: oct-MM-2005
Grant # BIOPHOT 26-02-0020
First Submitted: October 18, 2006
First Posted: October 19, 2006
Last Update Posted: October 19, 2006
Last Verified: October 2006

Keywords provided by Zealand University Hospital:
Optical coherence tomography

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Skin Diseases