Bioelectric Field Imaging in Diagnosing Melanoma and Other Skin Cancers in Patients With Skin Lesions

Development of an Electrical Diagnostic for Melanoma and Other Cutaneous Malignancies

RATIONALE: New diagnostic procedures, such as bioelectric field imaging, may help find and diagnose melanoma and other skin cancers. It may also be a less invasive way to check for skin cancer.

PURPOSE: This phase I trial is studying bioelectric field imaging in diagnosing melanoma and other skin cancers in patients with skin lesions.

Study Overview

• Status: Unknown
• Conditions: Melanoma (Skin); Non-melanomatous Skin Cancer
• Intervention / Treatment: Procedure: biopsy; Procedure: histopathologic examination; Procedure: bioelectric field imaging

Detailed Description

OBJECTIVES:

• To determine if the hand-held Bioelectric Field Imager can be used to measure the electric field in skin of various body surfaces, including face, neck, shoulders, arms, hands, chest, back, legs, and feet, during the course of examination and treatment of patients with suspected malignant skin lesions.
• To determine if there is a significant difference between the lateral electric field strength near benign and malignant skin lesions in the same individual.

OUTLINE: Patients undergo scanning of their skin lesions and nearby healthy skin using the Bioelectric Field Imager (BFI). The lesions are then biopsied for histological diagnosis. Histological data from the biopsy is correlated with the electric field data from the BFI.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Hampton, Virginia, United States, 23667
      • VA Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• Suspected malignant skin lesion
• Seeking treatment for skin lesion at the VA Medical Center

PATIENT CHARACTERISTICS:

• Not pregnant
• No acute illness, including upper respiratory tract infection or flu that could result in fever
• No trauma to the skin lesion area
• No prisoners

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Use of Bioelectric Field Imager (BFI) in measuring the electric field in skin of various body surfaces
Use of BFI in detecting significant electric field differences between malignant and benign skin lesions

Collaborators and Investigators

• Sponsor: Eastern Virginia Medical School
• Collaborators: National Cancer Institute (NCI); National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Antoinette F. Hood, MD, Eastern Virginia Medical School

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Anticipated): April 1, 2007
• Study Completion (Anticipated): April 1, 2007

Study Registration Dates

• First Submitted: October 2, 2006
• First Submitted That Met QC Criteria: October 20, 2006
• First Posted (Estimate): October 23, 2006

Study Record Updates

• Last Update Posted (Estimate): December 18, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: melanoma; squamous cell carcinoma of the skin; basal cell carcinoma of the skin
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Skin Neoplasms
• Other Study ID Numbers: CDR0000616117; EVMS-BFI and Lesions