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

Phase 1

• Conditions: Non-melanomatous Skin Cancer; Melanoma (Skin)

• Registration Number: NCT00391300
• Lead Sponsor: Eastern Virginia Medical School

Brief Summary

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.

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 Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-02
• Study First Submitted QC: 2006-10-20
• Study First Posted: 2006-10-23
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2008-10
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

VA Hospital; 🇺🇸 Hampton, Virginia, United States