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

This study is ongoing, but not recruiting participants.

First Received: October 2, 2006 Last Updated: February 6, 2009 History of Changes

Sponsors and Collaborators:	Eastern Virginia Medical School National Cancer Institute (NCI) National Institute of General Medical Sciences (NIGMS)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00391300

Purpose

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.

Condition	Intervention	Phase
Melanoma (Skin) Non-Melanomatous Skin Cancer	Procedure: bioelectric field imaging Procedure: biopsy Procedure: histopathologic examination	Phase I

MedlinePlus related topics: Cancer Melanoma Skin Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	Development of an Electrical Diagnostic for Melanoma and Other Cutaneous Malignancies

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Use of Bioelectric Field Imager (BFI) in measuring the electric field in skin of various body surfaces [ Designated as safety issue: No ]
Use of BFI in detecting significant electric field differences between malignant and benign skin lesions [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	October 2006
Estimated Study Completion Date:	April 2007
Estimated Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391300

Locations

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

Sponsors and Collaborators

Eastern Virginia Medical School

National Cancer Institute (NCI)

National Institute of General Medical Sciences (NIGMS)

Investigators

Principal Investigator:

Antoinette F. Hood, MD

Eastern Virginia Medical School

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000616117, EVMS-BFI and Lesions
Study First Received:	October 2, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00391300 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Skin Diseases
Carcinoma, Basal Cell
Skin Neoplasms
Squamous Cell Carcinoma
Melanoma
Carcinoma
Neuroendocrine Tumors

Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Epidermoid Carcinoma
Neuroepithelioma
Nevus
Carcinoma, Squamous Cell

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Skin Diseases
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Neoplasms
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on May 07, 2009