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
Recruitment status was Active, not recruiting
Sponsor:
Eastern Virginia Medical School
Collaborators:
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
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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 [ 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) |
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
Investigators
| Principal Investigator: | Antoinette F. Hood, MD | Eastern Virginia Medical School |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00391300 History of Changes |
| Other Study ID Numbers: | CDR0000616117, EVMS-BFI and Lesions |
| Study First Received: | October 2, 2006 |
| Last Updated: | February 6, 2009 |
| 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 |
Additional relevant MeSH terms:
|
Skin Neoplasms Melanoma Neoplasms by Site Neoplasms Skin Diseases Neuroendocrine Tumors |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 19, 2013