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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute of General Medical Sciences (NIGMS)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00391300
First received: October 2, 2006
Last updated: December 17, 2013
Last verified: October 2008
  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 1

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

Resource links provided by NLM:


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
  • Use of BFI in detecting significant electric field differences between malignant and benign skin lesions

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00391300     History of Changes
Other Study ID Numbers: CDR0000616117
EVMS-BFI and Lesions
Study First Received: October 2, 2006
Last Updated: December 17, 2013

Keywords provided by National Cancer Institute (NCI):
melanoma
basal cell carcinoma of the skin
squamous cell carcinoma of the skin

Additional relevant MeSH terms:
Melanoma
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on September 19, 2017