Confocal Reflectance Microscopy of Shave-Biopsy Sites on... | NCT00601185

Studies
Confocal Reflectance Microscopy of Shave-Biopsy Sites on Skin in Vivo.

NCT00601185

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Completed

Last Update Posted

Feb 27, 2018Actual

Enrollment

116Actual

Phase

Not provided

Conditions

Basal Cell Carcinoma
Melanoma
Squamous Cell Carcinoma
Non-Malignant Skin Disorders

Interventions

confocal microscopy in vivo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2006Actual

Primary Completion Date

Feb 23, 2018Actual

Completion Date

Feb 23, 2018Actual

First Submitted Date

Jan 14, 2008

First Submission Date that Met QC Criteria

Jan 14, 2008

First Posted Date

Jan 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2018

Last Update Posted Date

Feb 27, 2018Actual

Name	Class
National Institutes of Health (NIH)	NIH

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

116Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients undergoing a shave biopsy and confocal microscopy.	Procedure: confocal microscopy in vivo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
confocal microscopy in vivo	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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).
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.

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Dermatology clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kishwer Nehal, MD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Sloan Kettering at Basking Ridge		Basking Ridge	New Jersey	07920	United States
Memorial Sloan Kettering West Harrison

Label	URL
Memorial Sloan Kettering Cancer Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D002280	Carcinoma, Basal Cell
D008545	Melanoma
D002294	Carcinoma, Squamous Cell

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018613	Microscopy, Confocal

Ancestor Terms

ID	Term
D008853	Microscopy
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Link
NIH R01 EB0027-15,
R44 CA093106-02c
R44CA093106-02	U.S. NIH Grant/Contract	View source