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

NCT ID: NCT00391300

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-04-30

Brief Summary

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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

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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.

Conditions

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Melanoma (Skin) Non-melanomatous Skin Cancer

Keywords

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melanoma basal cell carcinoma of the skin squamous cell carcinoma of the skin

Study Design

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Primary Study Purpose

DIAGNOSTIC

Interventions

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bioelectric field imaging

Intervention Type PROCEDURE

biopsy

Intervention Type PROCEDURE

histopathologic examination

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

Eastern Virginia Medical School

OTHER

Sponsor Role lead

Principal Investigators

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Antoinette F. Hood, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern Virginia Medical School

Locations

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VA Hospital

Hampton, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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EVMS-BFI and Lesions

Identifier Type: -

Identifier Source: secondary_id

CDR0000616117

Identifier Type: -

Identifier Source: org_study_id