In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Memorial Sloan Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00588315
First received: December 24, 2007
Last updated: June 20, 2016
Last verified: June 2016
  Purpose

This study investigates new non-invasive imaging techniques for the evaluation of skin lesions, as well as normal skin. Our primary goal is to collect and study these images of different skin lesions along with matching biopsy specimens. The long-term goal is to develop a technique that will improve the early detection of skin cancer and eliminate the need for many skin biopsies.

The integrated handheld CSLM-OCT device will provide the first truly co-registered images of en face "optical section" planes (confocal) with orthogonal "optical section" planes (OCT).

The imaging with a polarization-sensitive hyper-spectral dermoscope (SkinSpect) will add to the interpretation of CLSM images. SkinSpect will produce tissue-level functional data (i. e., skin chromophore maps of melanin and hemoglobin) in larger fields of view, which will be combined with the cellular-level detail from CLSM imaging. The combined approach will be tested for more accurate detection of skin morphologic characteristics.


Condition
Skin Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • The study is a descriptive one. No formal statistical testing of correlations will be performed. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: November 1999
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
skin lesions
2
normal skin

  Eligibility

Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients of the Dermatology, Clinical Immunology Services, Pediatrics and Radiology Oncology departments that are determined to have a skin lesion with anticipated epidermal and superficial dermal histologic alterations amenable to visualization by surface confocal microscopy will be offered the opportunity to participate in the study.
Criteria

Inclusion Criteria:

  • Patients older than or equal to 10 years of age.
  • Patients with a skin lesion with anticipated epidermal and superficial dermal histologic alterations amenable to visualization by surface confocal microscopy.
  • Healthy volunteer subjects older than or equal to 10 years old.
  • Ability to give informed consent.

Exclusion Criteria:

  • Patients who are allergic to fluorescein sodium.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588315

Contacts
Contact: Allan Halpern, MD 646-888-6013
Contact: Ashfaq Marghoob, MD 646-888-6017

Locations
United States, New Jersey
Memoral Sloan Kettering Cancer Center Recruiting
Basking Ridge, New Jersey, United States
Contact: Allan Halpern, MD    646-888-6013      
United States, New York
Memorial Sloan Kettering Cancer Center Hauppauge Recruiting
Hauppauge, New York, United States, 11788
Contact: Allan Halpern, MD    646-888-6013      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Allan Halpern, MD    646-888-6013      
Contact: Ashfaq Marghoob, MD    646-888-6017      
Principal Investigator: Allan Halpern, MD         
Memorial Sloan Kettering West Harrison Recruiting
West Harrison, New York, United States, 10604
Contact: Allen Halpern, MD    646-888-6013      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Allan Halpern, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00588315     History of Changes
Other Study ID Numbers: 99-099 
Study First Received: December 24, 2007
Last Updated: June 20, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Skin Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2016