Melanoma (Skin)Phase 1NCT00391300
Bioelectric Field Imaging in Diagnosing Melanoma and Other Skin Cancers in Patients With Skin Lesions
A Phase 1 study testing bioelectric field imaging, biopsy and histopathologic examination in people with Melanoma (Skin) and Non-melanomatous Skin Cancer, run by Eastern Virginia Medical School at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin), Non-melanomatous Skin Cancer
- What is being tested?
- bioelectric field imaging, biopsy and histopathologic examination
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Apr 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Melanoma (Skin), Non-melanomatous Skin Cancer
- Being tested
- bioelectric field imaging, biopsy, histopathologic examination
- Keywords
- melanoma, basal cell carcinoma of the skin, squamous cell carcinoma of the skin
- Medical subject headings
- Melanoma, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioelectric field imagingProcedure or surgery
biopsyProcedure or surgery
histopathologic examinationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionApr 2007 (estimated)
- Study completionApr 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of General Medical Sciences (NIGMS)
- Investigators
- Antoinette F. Hood, MD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391300
- Sponsor's protocol ID
- CDR0000616117
- Other IDs
- EVMS-BFI and Lesions
- Status last verified
- Oct 2008
- First submitted
- 2 Oct 2006
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Electrical Diagnostic for Melanoma and Other Cutaneous Malignancies
- ClinicalTrials.gov ID
- NCT00391300
- Acronym / sponsor ID
- CDR0000616117
- Conditions
- Melanoma (Skin), Non-melanomatous Skin Cancer
- Keywords
- melanoma, basal cell carcinoma of the skin, squamous cell carcinoma of the skin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of General Medical Sciences (NIGMS)
- Study start
- Oct 2006
- Primary completion
- Apr 2007 (estimated)
- Study completion
- Apr 2007 (estimated)
- First posted
- 23 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bioelectric field imaging | Procedure or surgery | – |
| biopsy | Procedure or surgery | – |
| histopathologic examination | Procedure or surgery | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoinette F. Hood, MD principal investigator
Eastern Virginia Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bioelectric field imaging, biopsy and histopathologic examination in people with Melanoma (Skin) and Non-melanomatous Skin Cancer, run by Eastern Virginia Medical School at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Bioelectric Field Imager (BFI) in measuring the electric field in skin of various body surfaces. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.