Skin CancerNCT00432471
Optical Imaging of Skin Cancers for Margin Delineation of Non-Melanoma Skin Cancers
A study testing Optical Imaging in people with Skin Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to evaluate an experimental imaging technology, the multispectral digital microscope (MDM), which may help doctors see how far skin cancer extends (widens out) on an area of skin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Optical Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2007to 25 Jun 2017
- Phase
- Interventional
- 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
Who may be able to join
- Patients who will be undergoing surgery to remove a region of skin suspected of containing non-melanoma skin cancer will be eligible to participate in this study. The proposed resection should be equal or greater than 1 cm in diameter.
- In addition, patients undergoing induction chemotherapy or biologic therapy prior to surgical resection are also eligible.
- Patients must sign an informed consent indicating awareness of the investigational nature of this study.
Who cannot join
- Patients with non-melanoma skin cancer lesion at eyelid, or in case that the lesion extends to superior or inferior eyelid, this area will not be imaged.
- Persons who are medically unfit to undergo resection of skin lesions.
- Persons under the age of 18.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Evaluation of Optical Imaging for Margin Delineation of Non-Melanoma Skin Cancers
The goal of this clinical research study is to evaluate an experimental imaging technology, the multispectral digital microscope (MDM), which may help doctors see how far skin cancer extends (widens out) on an area of skin. Researchers want to learn if this new technology can help doctors identify the exact areas involved in precancerous or cancerous changes in the skin.
Read the detailed description
All tissue and cells are made of tiny particles that give off small amounts of light. This light is called fluorescence. Researchers have learned that cancerous cells and normal cells give off different amounts and different types of fluorescence. Cancerous cells and normal cells also reflect (bounce back) light differently. Researchers want to better understand if light fluorescence and reflectance (a measure of the ability of a material to reflect sunlight) from the skin can be used to tell which cells may be cancerous.
Researchers have developed the MDM system in order to better understand how cancer changes the light fluorescence and reflectance in skin. The MDM system shines different colors of light on the skin and takes pictures of fluorescence and reflectance on the skin area through a microscope. The pictures will then be studied to better understand the differences in fluorescence and reflectance in abnormal and normal cells.
If you agree to take part in this study, an area of your skin will first be examined under standard white light. A researcher will then use the MDM imaging instrument to take pictures of abnormal-looking and normal skin areas. The researcher will mark 2-4 areas of your skin with a marker. During your surgery, you will have a small sample from a normal-looking area collected and 1 or 2 samples collected, from abnormal-looking areas of the skin. Each sample from abnormal-looking tissue will be about 3-4 millimeters wide (about the size of a small pencil eraser).
After the skin lesion has been removed, but before it is needed for review by the pathologist or surgeon, the removed tissue will be examined using the MDM imaging instrument and standard white light. The edges of the removed lesion will then be examined with another type of microscope, a confocal microscope, which allows researchers to see the very small cells in the tissue. The exact location that was imaged with this microscope will be marked on the tissue, and the findings will be recorded. The tissue will then be checked by the pathologist according to standard procedures.
You will not be told of any of the experimental findings. Information about the diagnosis will be available to your treating doctor.
Your name and any personal identifying information (such as your name, social security number, or medical record number) will be coded to protect your privacy.
This is an investigational study. Up to 55 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Skin Cancer
- Being tested
- Optical Imaging
- Keywords
- Skin Cancer, Non-Melanoma Skin Cancer, Optical Imaging, Multispectral Digital Microscope System, MDM
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical ImagingProcedure or surgery
Imaging using the multispectral digital microscope (MDM), a system that shines different colors of light on the skin and takes pictures of fluorescence and reflectance on the skin area.
| Study group | Role | What they receive |
|---|---|---|
| Optical Imaging | Experimental | Imaging using the multispectral digital microscope (MDM), a system that shines different colors of light on the skin and takes pictures of fluorescence and reflectance on the skin area. Receives: Procedure: Optical Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate use of fluorescence and reflectance imaging, and confocal microscopy for non-invasive detection of skin tumor margins in head and neck region
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2007 (estimated)
- Study start30 Jan 2007
- Primary completion25 Jun 2017
- Study completion25 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Ann M. Gillenwater, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432471
- Sponsor's protocol ID
- 2006-0493
- Other IDs
- 1R21DE016485-01, NCI-2015-01901
- Status last verified
- Jun 2017
- First submitted
- 5 Feb 2007
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Optical Imaging for Margin Delineation of Non-Melanoma Skin Cancers
- ClinicalTrials.gov ID
- NCT00432471
- Acronym / sponsor ID
- 2006-0493
- Conditions
- Skin Cancer
- Keywords
- Skin Cancer, Non-Melanoma Skin Cancer, Optical Imaging, Multispectral Digital Microscope System, MDM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 30 Jan 2007 (actual)
- Primary completion
- 25 Jun 2017 (actual)
- Study completion
- 25 Jun 2017 (actual)
- First posted
- 7 Feb 2007 (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.
The goal of this clinical research study is to evaluate an experimental imaging technology, the multispectral digital microscope (MDM), which may help doctors see how far skin cancer extends (widens out) on an area of skin. Researchers want to learn if this new technology can help doctors identify the exact areas involved in precancerous or cancerous changes in the skin.
Detailed description
All tissue and cells are made of tiny particles that give off small amounts of light. This light is called fluorescence. Researchers have learned that cancerous cells and normal cells give off different amounts and different types of fluorescence. Cancerous cells and normal cells also reflect (bounce back) light differently. Researchers want to better understand if light fluorescence and reflectance (a measure of the ability of a material to reflect sunlight) from the skin can be used to tell which cells may be cancerous.
Researchers have developed the MDM system in order to better understand how cancer changes the light fluorescence and reflectance in skin. The MDM system shines different colors of light on the skin and takes pictures of fluorescence and reflectance on the skin area through a microscope. The pictures will then be studied to better understand the differences in fluorescence and reflectance in abnormal and normal cells.
If you agree to take part in this study, an area of your skin will first be examined under standard white light. A researcher will then use the MDM imaging instrument to take pictures of abnormal-looking and normal skin areas. The researcher will mark 2-4 areas of your skin with a marker. During your surgery, you will have a small sample from a normal-looking area collected and 1 or 2 samples collected, from abnormal-looking areas of the skin. Each sample from abnormal-looking tissue will be about 3-4 millimeters wide (about the size of a small pencil eraser).
After the skin lesion has been removed, but before it is needed for review by the pathologist or surgeon, the removed tissue will be examined using the MDM imaging instrument and standard white light. The edges of the removed lesion will then be examined with another type of microscope, a confocal microscope, which allows researchers to see the very small cells in the tissue. The exact location that was imaged with this microscope will be marked on the tissue, and the findings will be recorded. The tissue will then be checked by the pathologist according to standard procedures.
You will not be told of any of the experimental findings. Information about the diagnosis will be available to your treating doctor.
Your name and any personal identifying information (such as your name, social security number, or medical record number) will be coded to protect your privacy.
This is an investigational study. Up to 55 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optical Imaging | Experimental | Procedure: Optical ImagingImaging using the multispectral digital microscope (MDM), a system that shines different colors of light on the skin and takes pictures of fluorescence and reflectance on the skin area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who will be undergoing surgery to remove a region of skin suspected of containing non-melanoma skin cancer will be eligible to participate in this study. The proposed resection should be equal or greater than 1 cm in diameter.
- In addition, patients undergoing induction chemotherapy or biologic therapy prior to surgical resection are also eligible.
- Patients must sign an informed consent indicating awareness of the investigational nature of this study.
Key exclusion criteria (3 listed)
- Patients with non-melanoma skin cancer lesion at eyelid, or in case that the lesion extends to superior or inferior eyelid, this area will not be imaged.
- Persons who are medically unfit to undergo resection of skin lesions.
- Persons under the age of 18.
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 |
|---|---|---|
| Optical ImagingImaging using the multispectral digital microscope (MDM), a system that shines different colors of light on the skin and takes pictures of fluorescence and reflectance on the skin area. | Procedure or surgery | Optical Imaging |
Primary outcome
Evaluate use of fluorescence and reflectance imaging, and confocal microscopy for non-invasive detection of skin tumor margins in head and neck region
Time frame: 4 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Ann M. Gillenwater, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Imaging in people with Skin Cancer, run by M.D. Anderson Cancer Center 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?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 28 Jun 2017. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate use of fluorescence and reflectance imaging, and confocal microscopy for non-invasive detection of skin tumor margins in head and neck region (time frame: 4 Years). 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 28 Jun 2017.