Confocal Reflectance Microscopy of Shave-Biopsy Sites on Skin in Vivo.
4 other identifiers
observational
116
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2006
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 14, 2006
CompletedFirst Submitted
Initial submission to the registry
January 14, 2008
CompletedFirst Posted
Study publicly available on registry
January 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2018
CompletedFebruary 27, 2018
February 1, 2018
12 years
January 14, 2008
February 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
is to evaluate and quantify the technical feasibility of reflectance CSLM imaging of shave-biopsy sites on skin in vivo.
conclusion of study
Secondary Outcomes (1)
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.
conclusion of study
Study Arms (1)
1
Patients undergoing a shave biopsy and confocal microscopy.
Interventions
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 Criteria
Dermatology clinic
You may qualify if:
- Patients undergoing shave-biopsy on an anatomical site that is readily accessible to the VivaScope 1500 (for example, chest, back, legs, arms, cheek, forehead).
- The additional 110 patients for this amendment will be imaged with the newly developed Vivascope 3000 handheld confocal microscope.
- Ability to sign informed consent.
- Age ≥ 18 years.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering West Harrison
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center Hauppauge
Hauppauge, New York, 11788, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kishwer Nehal, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2008
First Posted
January 25, 2008
Study Start
February 14, 2006
Primary Completion
February 23, 2018
Study Completion
February 23, 2018
Last Updated
February 27, 2018
Record last verified: 2018-02