Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390351
Status:
UNKNOWN
Last Update Posted:
2006-10-19
First Post:
2006-10-18
Brief Title:
Investigate the Diagnostic Value and Possibilities of OCT in Non-Melanoma Skin Cancer
Sponsor:
Zealand University Hospital
Organization:
Zealand University Hospital
Study Overview
Official Title:
Diagnosis of Non-Melanoma Skin Cancer With Optical Coherence Tomography
Status:
UNKNOWN
Status Verified Date:
2006-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Grant BIOPHOT 26-02-0020 | None | None | None |