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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 because the information has not been verified recently.
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: February 6, 2009
Last verified: October 2008
History of Changes

October 2, 2006
February 6, 2009
October 2006
April 2007   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00391300 on ClinicalTrials.gov Archive Site
Not Provided
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Bioelectric Field Imaging in Diagnosing Melanoma and Other Skin Cancers in Patients With Skin Lesions
Development of an Electrical Diagnostic for Melanoma and Other Cutaneous Malignancies

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.

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.
Interventional
Phase 1
Primary Purpose: Diagnostic
  • Melanoma (Skin)
  • Non-Melanomatous Skin Cancer
  • Procedure: bioelectric field imaging
  • Procedure: biopsy
  • Procedure: histopathologic examination
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
April 2007
April 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00391300
CDR0000616117, EVMS-BFI and Lesions
No
Not Provided
Eastern Virginia Medical School
  • National Cancer Institute (NCI)
  • National Institute of General Medical Sciences (NIGMS)
Principal Investigator: Antoinette F. Hood, MD Eastern Virginia Medical School
National Cancer Institute (NCI)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP