Oral CancerNCT00502580
Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions
An observational study of Oral Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To obtain data to evaluate whether multispectral digital imaging can assist clinicians to screen for premalignant lesions in the oral cavity. Our system will illuminate tissue with monochromatic light to excite fluorescence, and polarized white light to generate reflectance, exposing abnormalities for real time… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Interview
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Mar 2008
- Phase
- Observational
- 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
Study population: Patients with lesions of the oral cavity mucosa.
Who may be able to join
- Subjects with lesions of the oral cavity mucosa or suspicious for malignancy or premalignancy.
- Subjects with the ability and willingness to sign an informed consent and authorization.
- Subjects who develop new lesions or alterations in long-standing lesions are eligible, but not required, for re-examination with informed consent.
Who cannot join
- Persons who are medically unfit to undergo superficial punch biopsies of oral mucosa.
- Persons under the age of 18.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
To obtain data to evaluate whether multispectral digital imaging can assist clinicians to screen for premalignant lesions in the oral cavity. Our system will illuminate tissue with monochromatic light to excite fluorescence, and polarized white light to generate reflectance, exposing abnormalities for real time, clinical diagnosis.
Primary Objectives:
- To compare fluorescence images of oral mucosa lesions, obtained at 350 nm, 380 nm, 400 nm, and 450 nm excitation, to standard white light images and pathologic analysis of biopsied tissue.
- To compare reflectance images of oral mucosa lesion, obtained using broadband polarized light, to standard white light images and pathologic analysis of biopsied tissue.
- To develop algorithms to discriminate between normal and abnormal tissue
- To analyze images to determine which type of optical information (or combination thereof) yields the most diagnostically useful data
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. Scientists have learned that cancerous cells and normal cells give off different amounts and different types of fluorescence. Scientists need to better understand whether fluorescence from the oral cavity (mouth) can be used to tell which cells are abnormal. This information can help doctors detect pre-cancers.
In order to better understand fluorescence, researchers at the Optical Spectroscopy and Imaging Lab, Department of Bioengineering, Rice University have developed an instrument that can collect and analyze fluorescence without surgically removing any tissue or touching the tissue. This instrument takes pictures of oral cavity fluorescence through a microscope. The instrument also takes regular live pictures. Scientists hope to study the pictures to better understand the differences in fluorescence from normal and abnormal cells. The instrument is a standard medical microscope similar to ones used by doctors in their offices to examine people's ears. Researchers have attached a special light source to the microscope that provides different colors of light. In addition, the microscope has a digital camera attached to it so that the researchers can record what they see with the different light colors.
In this study, a clinician will use the instrument to take pictures of suspicious and normal oral cavity lesions. A small sample of the oral lesion (2-4 mm each, the size of a small eraser) will be removed or biopsied from the areas that are imaged. A portion of both the suspicious and normal areas will be taken to pathology for evaluation. The biopsy from the normal appearing area is a biopsy that is additional to those you will receive as part of your standard of care. Each participant will have 2-4 biopsies performed, depending upon how many areas the examiner feels may be suspicious. Most people who take part in this study will be having surgery to remove lesions in the oral cavity anyway, so the biopsies will be performed at the time of surgery. For those participants who are not scheduled to have surgery, the biopsies will be performed under local anesthesia in the clinic.
All data will be numerically coded to ensure your confidentiality.
In addition to the pictures taken and the biopsy, a brief interview will be performed by the clinical research staff to discuss possible past local therapies and your personal history of tobacco and alcohol use. The interview should take about 10 minutes to complete.
You will not be told of any of the experimental findings. Information confirming the diagnosis will be made available to your treating physician. After this visit and tissue collection, your participation in this study will be complete.
This is an investigational study. A total of 45 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Oral Cancer
- Being tested
- Interview
- Keywords
- Oral Cancer, Multispectral Digital Microscope, Multispectral Digital Imaging, Interview, MDM
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
Interview taking about 10 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with lesions of the oral cavity mucosa. Receives: Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate new imaging technology, MDM (Multispectral Digital Microscope), as a tool for early diagnosis of oral neoplasia
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 posted17 Jul 2007 (estimated)
- Study startJul 2005
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), 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
- NCT00502580
- Sponsor's protocol ID
- 2004-0684
- Status last verified
- Jul 2012
- First submitted
- 13 Jul 2007
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions
- ClinicalTrials.gov ID
- NCT00502580
- Acronym / sponsor ID
- 2004-0684
- Conditions
- Oral Cancer
- Keywords
- Oral Cancer, Multispectral Digital Microscope, Multispectral Digital Imaging, Interview, MDM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Jul 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 17 Jul 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.
To obtain data to evaluate whether multispectral digital imaging can assist clinicians to screen for premalignant lesions in the oral cavity. Our system will illuminate tissue with monochromatic light to excite fluorescence, and polarized white light to generate reflectance, exposing abnormalities for real time, clinical diagnosis.
Primary Objectives:
- To compare fluorescence images of oral mucosa lesions, obtained at 350 nm, 380 nm, 400 nm, and 450 nm excitation, to standard white light images and pathologic analysis of biopsied tissue.
- To compare reflectance images of oral mucosa lesion, obtained using broadband polarized light, to standard white light images and pathologic analysis of biopsied tissue.
- To develop algorithms to discriminate between normal and abnormal tissue
- To analyze images to determine which type of optical information (or combination thereof) yields the most diagnostically useful data
Detailed description
All tissue and cells are made of tiny particles that give off small amounts of light. This light is called fluorescence. Scientists have learned that cancerous cells and normal cells give off different amounts and different types of fluorescence. Scientists need to better understand whether fluorescence from the oral cavity (mouth) can be used to tell which cells are abnormal. This information can help doctors detect pre-cancers.
In order to better understand fluorescence, researchers at the Optical Spectroscopy and Imaging Lab, Department of Bioengineering, Rice University have developed an instrument that can collect and analyze fluorescence without surgically removing any tissue or touching the tissue. This instrument takes pictures of oral cavity fluorescence through a microscope. The instrument also takes regular live pictures. Scientists hope to study the pictures to better understand the differences in fluorescence from normal and abnormal cells. The instrument is a standard medical microscope similar to ones used by doctors in their offices to examine people's ears. Researchers have attached a special light source to the microscope that provides different colors of light. In addition, the microscope has a digital camera attached to it so that the researchers can record what they see with the different light colors.
In this study, a clinician will use the instrument to take pictures of suspicious and normal oral cavity lesions. A small sample of the oral lesion (2-4 mm each, the size of a small eraser) will be removed or biopsied from the areas that are imaged. A portion of both the suspicious and normal areas will be taken to pathology for evaluation. The biopsy from the normal appearing area is a biopsy that is additional to those you will receive as part of your standard of care. Each participant will have 2-4 biopsies performed, depending upon how many areas the examiner feels may be suspicious. Most people who take part in this study will be having surgery to remove lesions in the oral cavity anyway, so the biopsies will be performed at the time of surgery. For those participants who are not scheduled to have surgery, the biopsies will be performed under local anesthesia in the clinic.
All data will be numerically coded to ensure your confidentiality.
In addition to the pictures taken and the biopsy, a brief interview will be performed by the clinical research staff to discuss possible past local therapies and your personal history of tobacco and alcohol use. The interview should take about 10 minutes to complete.
You will not be told of any of the experimental findings. Information confirming the diagnosis will be made available to your treating physician. After this visit and tissue collection, your participation in this study will be complete.
This is an investigational study. A total of 45 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: InterviewPatients with lesions of the oral cavity mucosa. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lesions of the oral cavity mucosa.
Key inclusion criteria (3 listed)
- Subjects with lesions of the oral cavity mucosa or suspicious for malignancy or premalignancy.
- Subjects with the ability and willingness to sign an informed consent and authorization.
- Subjects who develop new lesions or alterations in long-standing lesions are eligible, but not required, for re-examination with informed consent.
Key exclusion criteria (2 listed)
- Persons who are medically unfit to undergo superficial punch biopsies of oral mucosa.
- 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 |
|---|---|---|
| InterviewInterview taking about 10 minutes to complete. | Behavioural | 1 |
Primary outcome
Evaluate new imaging technology, MDM (Multispectral Digital Microscope), as a tool for early diagnosis of oral neoplasia
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 30 Jul 2012.
- UT 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?
An observational study of Oral 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 2 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 30 Jul 2012. 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 new imaging technology, MDM (Multispectral Digital Microscope), as a tool for early diagnosis of oral neoplasia (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 30 Jul 2012.