Overview

This trial is active, not recruiting.

Conditions melanoma (skin), non-melanomatous skin cancer
Treatments bioelectric field imaging, biopsy, histopathologic examination
Phase phase 1
Sponsor Eastern Virginia Medical School
Collaborator National Cancer Institute (NCI)
Start date October 2006
End date April 2007
Trial size 100 participants
Trial identifier NCT00391300, CDR0000616117, EVMS-BFI and Lesions

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose diagnostic

Primary Outcomes

Measure
Use of Bioelectric Field Imager (BFI) in measuring the electric field in skin of various body surfaces
time frame:
Use of BFI in detecting significant electric field differences between malignant and benign skin lesions
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Development of an Electrical Diagnostic for Melanoma and Other Cutaneous Malignancies
Principal investigator Antoinette F. Hood, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).