Confocal Reflectance Microscopy of Shave-Biopsy Sites on Skin in Vivo.
This study is currently recruiting participants.
Verified March 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00601185
First received: January 14, 2008
Last updated: March 18, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to evaluate a new instrument that shines light and takes digital pictures of skin. The goal is to develop a technique that may enable fast and accurate detection of skin disorders and cancers for future clinical diagnosis and surgical use.
| Condition | Intervention |
|---|---|
|
Basal Cell Carcinoma Melanoma Squamous Cell Carcinoma Non-Malignant Skin Disorders |
Procedure: confocal microscopy in vivo |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Confocal Reflectance Microscopy of Shave-Biopsy Sites on Skin in Vivo |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- is to evaluate and quantify the technical feasibility of reflectance CSLM imaging of shave-biopsy sites on skin in vivo. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess the quality of the CSLM images of the biopsy sites to determine a point estimate of the proportion of images that will be of acceptable quality for formal analysis in the planned study of intraoperative margin detection. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Patients undergoing a shave biopsy and confocal microscopy.
|
Procedure: confocal microscopy in vivo
A dermatologist will perform a shave biopsy according to standard clinical procedures. This study will be carried out after the shave biopsy. The deep surface and the peripheral margins will be imaged on each patient.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients undergoing shave-biopsy on an anatomical site that is readily accessible to the VivaScope 1500 (for example, chest, back, legs, arms, cheek, forehead).
- Ability to sign informed consent.
- Age > 18 years.
Exclusion Criteria:
- Shave-biopsy located on a site that is not amenable to confocal imaging (for example, adjacent to the nose, ears or eyes, fingers, toes).
- Inability to give informed consent.
- Known hypersensitivity to adhesive rings.
- Inability to tolerate imaging procedure (i. e., remain relatively still for multiple short durations of 3-4 minutes).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601185
Contacts
| Contact: Kishwer Nehal, MD | 212-610-0782 | |
| Contact: Allan Halpern, MD | 212-610-0766 |
Locations
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Kishwer Nehal, MD 212-610-0782 | |
| Contact: Allan Halpern, MD 212-610-0766 | |
| Principal Investigator: Kishwer Nehal, MD | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Kishwer Nehal, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00601185 History of Changes |
| Other Study ID Numbers: | 06-009, NIH R01 EB0027-15,, R44 CA093106-02c |
| Study First Received: | January 14, 2008 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Basal Cell Carcinoma, Squamous Cell Melanoma Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Basal Cell Neoplasms, Squamous Cell Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 22, 2013