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

Primary Purpose

Melanoma (Skin), Non-melanomatous Skin Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
bioelectric field imaging
biopsy
histopathologic examination
Sponsored by
Eastern Virginia Medical School
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Melanoma (Skin) focused on measuring melanoma, basal cell carcinoma of the skin, squamous cell carcinoma of the skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 2, 2006
Last Updated
December 17, 2013
Sponsor
Eastern Virginia Medical School
Collaborators
National Cancer Institute (NCI), National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00391300
Brief Title
Bioelectric Field Imaging in Diagnosing Melanoma and Other Skin Cancers in Patients With Skin Lesions
Official Title
Development of an Electrical Diagnostic for Melanoma and Other Cutaneous Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2007 (Anticipated)
Study Completion Date
April 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Virginia Medical School
Collaborators
National Cancer Institute (NCI), National Institute of General Medical Sciences (NIGMS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin), Non-melanomatous Skin Cancer
Keywords
melanoma, basal cell carcinoma of the skin, squamous cell carcinoma of the skin

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
bioelectric field imaging
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Type
Procedure
Intervention Name(s)
histopathologic examination
Primary Outcome Measure Information:
Title
Use of Bioelectric Field Imager (BFI) in measuring the electric field in skin of various body surfaces
Title
Use of BFI in detecting significant electric field differences between malignant and benign skin lesions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoinette F. Hood, MD
Organizational Affiliation
Eastern Virginia Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Hospital
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23667
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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