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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Squamous Cell Carcinoma; Melanoma; Non-Malignant Skin Disorders; Basal Cell Carcinoma

Treatments: Procedure: confocal microscopy in vivo

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00601185

R44 CA093106-02c

06-009

NIH R01 EB0027-15,

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

116 participants in 1 patient group

1

Description:

Patients undergoing a shave biopsy and confocal microscopy.

Treatment:

Procedure: confocal microscopy in vivo