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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Roskilde County Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Roskilde County Hospital
ClinicalTrials.gov Identifier:
NCT00390351
First received: October 18, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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
Official Title: Diagnosis of Non-Melanoma Skin Cancer With Optical Coherence Tomography

Resource links provided by NLM:


Further study details as provided by Roskilde County 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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: NCT00390351

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

Locations
Denmark
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
Roskilde County Hospital
Investigators
Principal Investigator: Mette Mogensen, MD Dept. of Dermatology, Roskilde Hospital
Study Director: Gregor BE Jemec, MD, DMSc Dept. of Dermatology, Roskilde Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00390351     History of Changes
Other Study ID Numbers: oct-MM-2005, Grant # BIOPHOT 26-02-0020
Study First Received: October 18, 2006
Last Updated: October 18, 2006
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Roskilde County Hospital:
Optical coherence tomography

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

ClinicalTrials.gov processed this record on September 18, 2014