ErythroplakiaNCT00542373
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
A study testing Cytology Specimen Collection Procedure, Diagnostic Microscopy and Diagnostic Procedure in people with Erythroplakia and Fanconi Anemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies widefield fluorescence and reflectance imaging, fluorescence spectroscopy, and tissue samples in regularly examining (monitoring) participants at risk for developing oral cancer. All tissue and cells are made of tiny particles. Some of these particles give off small amounts of light. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythroplakia, Fanconi Anemia, Lichen Planus
- What is being tested?
- Cytology Specimen Collection Procedure, Diagnostic Microscopy and Diagnostic Procedure
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2007to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subjects with premalignant lesion, or potentially premalignant lesion, of the oral cavity mucosa (leukoplakia or erythroplakia)
- Patients with a history of head and neck cancer or oral premalignant disease but without any clinical evidence of disease
- Persons with any other condition (such as lichen planus, Fanconi anemia, heavy tobacco use, etc) making them at higher risk for oral cancer development
- Patients with either pre-malignant or a history of oral cancer based on patient history and clinical presentations
Who cannot join
- Subjects under the age of 18.
- Subjects that are unable or unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluorescence & Reflectance Imaging to Detect Oral Neoplasia
This clinical trial studies widefield fluorescence and reflectance imaging, fluorescence spectroscopy, and tissue samples in regularly examining (monitoring) participants at risk for developing oral cancer. All tissue and cells are made of tiny particles. Some of these particles give off small amounts of light. This light is called fluorescence. Fluorescent imaging use instruments that shine different wavelengths (colors) of light in the mouth taking fluorescence pictures through a portable head light or by taking fluorescent and reflectance pictures through a dental microscope using a digital camera. Fluorescent spectroscopy uses a small probe placed gently against the lining of the mouth and the tissue is exposed to small amounts of fluorescent light that is then collected with a special camera and a computer to be analyzed. Checking mouth tissue samples under a microscope may also help detect abnormal cells. Diagnostic procedures, such as fluorescence and reflectance imaging, fluorescence spectroscopy imaging, and tissue samples, may help doctors detect pre-cancer or early cancer when it may be easier to treat.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare images of oral mucosa, obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation, to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression.
OUTLINE:
Participants' oral cavities are inspected by a clinician using a standard white light headlamp. Participants then undergo oral mucosa examination using wide-field reflectance and fluorescence imaging, and/or fluorescence spectroscopy imaging. Standard oral brush biopsies are also performed and examined microscopically. Participants may undergo repeated imaging procedures and biopsy during subsequent follow up visits.
- Conditions
- Erythroplakia, Fanconi Anemia, Lichen Planus, Oral Cavity and Lip Precancerous Condition, Oral Cavity Leukoplakia, Oral Neoplasm
- Being tested
- Cytology Specimen Collection Procedure, Diagnostic Microscopy, Diagnostic Procedure, Fluorescence Imaging, Fluorescence Spectroscopy
- Medical subject headings
- Erythroplasia, Fanconi Anemia, Lichen Planus, Leukokeratosis, Hereditary Mucosal, Mouth Neoplasms, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Undergo oral tissue collection
Diagnostic MicroscopyProcedure or surgery
Mouth tissue examined microscopically for cytologic features
Diagnostic ProcedureProcedure or surgery
Also called Diagnostic Method, Diagnostic Technique, Diagnostic Test
Undergo standard white light headlamp oral examination
Fluorescence ImagingProcedure or surgery
Undergo widefield fluorescent and reflectance imaging
Fluorescence SpectroscopyProcedure or surgery
Also called Spectroscopy, Fluorescence
Undergo point fluorescent spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (fluorescent/reflectance imaging, spectroscopy) | Experimental | Participants' oral cavities are inspected by a clinician using a standard white light headlamp. Participants then undergo oral mucosa examination using wide-field reflectance and fluorescence imaging, and/or fluorescence spectroscopy imaging. Standard oral brush biopsies are also performed and examined microscopically. Participants may undergo repeated imaging procedures and biopsy during subsequent follow up visits. Receives: Other: Cytology Specimen Collection Procedure; Procedure: Diagnostic Microscopy; Procedure: Diagnostic Procedure; Procedure: Fluorescence Imaging; Procedure: Fluorescence Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesions diagnosed via wide-field fluorescence imaging
Oral mucosa obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation will be compared to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression. Diagnostic methods will be compared with each other by forming 2x2 tables and computing the chi-square statistics for the McNemar test. Kappa statistic will also be calculated for comparing the chance corrected agreement between various diagnostic methods.
Measured: Up to 10 years
Lesions diagnosed via point spectroscopy system
Oral mucosa obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation will be compared to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression. Diagnostic methods will be compared with each other by forming 2x2 tables and computing the chi-square statistics for the McNemar test. Kappa statistic will also be calculated for comparing the chance corrected agreement between various diagnostic methods.
Measured: Up to 10 years
Lesions diagnosed via non-invasive brush cytology
Oral mucosa obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation will be compared to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression. Diagnostic methods will be compared with each other by forming 2x2 tables and computing the chi-square statistics for the McNemar test. Kappa statistic will also be calculated for comparing the chance corrected agreement between various diagnostic methods.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study start27 Aug 2007
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErythroplakiaStudies 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
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ann M Gillenwater, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542373
- Sponsor's protocol ID
- 2006-0802
- Other IDs
- P30CA016672, NCI-2015-01903, 2006-0802
- Status last verified
- Sep 2026
- First submitted
- 10 Oct 2007
- Last updated
- 14 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence & Reflectance Imaging to Detect Oral Neoplasia
- ClinicalTrials.gov ID
- NCT00542373
- Acronym / sponsor ID
- 2006-0802
- Conditions
- Erythroplakia, Fanconi Anemia, Lichen Planus, Oral Cavity and Lip Precancerous Condition, Oral Cavity Leukoplakia, Oral Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 338 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Aug 2007 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 11 Oct 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.
This clinical trial studies widefield fluorescence and reflectance imaging, fluorescence spectroscopy, and tissue samples in regularly examining (monitoring) participants at risk for developing oral cancer. All tissue and cells are made of tiny particles. Some of these particles give off small amounts of light. This light is called fluorescence. Fluorescent imaging use instruments that shine different wavelengths (colors) of light in the mouth taking fluorescence pictures through a portable head light or by taking fluorescent and reflectance pictures through a dental microscope using a digital camera. Fluorescent spectroscopy uses a small probe placed gently against the lining of the mouth and the tissue is exposed to small amounts of fluorescent light that is then collected with a special camera and a computer to be analyzed. Checking mouth tissue samples under a microscope may also help detect abnormal cells. Diagnostic procedures, such as fluorescence and reflectance imaging, fluorescence spectroscopy imaging, and tissue samples, may help doctors detect pre-cancer or early cancer when it may be easier to treat.
Detailed description
PRIMARY OBJECTIVES:
- To compare images of oral mucosa, obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation, to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression.
OUTLINE:
Participants' oral cavities are inspected by a clinician using a standard white light headlamp. Participants then undergo oral mucosa examination using wide-field reflectance and fluorescence imaging, and/or fluorescence spectroscopy imaging. Standard oral brush biopsies are also performed and examined microscopically. Participants may undergo repeated imaging procedures and biopsy during subsequent follow up visits.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (fluorescent/reflectance imaging, spectroscopy) | Experimental | Other: Cytology Specimen Collection Procedure, Procedure: Diagnostic Microscopy, Procedure: Diagnostic Procedure, Procedure: Fluorescence Imaging, Procedure: Fluorescence SpectroscopyParticipants' oral cavities are inspected by a clinician using a standard white light headlamp. Participants then undergo oral mucosa examination using wide-field reflectance and fluorescence imaging, and/or fluorescence spectroscopy imaging. Standard oral brush biopsies are also performed and examined microscopically. Participants may undergo repeated imaging procedures and biopsy during subsequent follow up visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with premalignant lesion, or potentially premalignant lesion, of the oral cavity mucosa (leukoplakia or erythroplakia)
- Patients with a history of head and neck cancer or oral premalignant disease but without any clinical evidence of disease
- Persons with any other condition (such as lichen planus, Fanconi anemia, heavy tobacco use, etc) making them at higher risk for oral cancer development
- Patients with either pre-malignant or a history of oral cancer based on patient history and clinical presentations
Key exclusion criteria (2 listed)
- Subjects under the age of 18.
- Subjects that are unable or unwilling to give informed consent
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 |
|---|---|---|
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingUndergo oral tissue collection | Other | Diagnostic (fluorescent/reflectance imaging, spectroscopy) |
| Diagnostic MicroscopyMouth tissue examined microscopically for cytologic features | Procedure or surgery | Diagnostic (fluorescent/reflectance imaging, spectroscopy) |
| Diagnostic ProcedureAlso: Diagnostic Method, Diagnostic Technique, Diagnostic TestUndergo standard white light headlamp oral examination | Procedure or surgery | Diagnostic (fluorescent/reflectance imaging, spectroscopy) |
| Fluorescence ImagingUndergo widefield fluorescent and reflectance imaging | Procedure or surgery | Diagnostic (fluorescent/reflectance imaging, spectroscopy) |
| Fluorescence SpectroscopyAlso: Spectroscopy, FluorescenceUndergo point fluorescent spectroscopy | Procedure or surgery | Diagnostic (fluorescent/reflectance imaging, spectroscopy) |
Primary outcome
Lesions diagnosed via wide-field fluorescence imaging
Time frame: Up to 10 years
Oral mucosa obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation will be compared to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression. Diagnostic methods will be compared with each other by forming 2x2 tables and computing the chi-square statistics for the McNemar test. Kappa statistic will also be calculated for comparing the chance corrected agreement between various diagnostic methods.
Lesions diagnosed via point spectroscopy system
Time frame: Up to 10 years
Oral mucosa obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation will be compared to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression. Diagnostic methods will be compared with each other by forming 2x2 tables and computing the chi-square statistics for the McNemar test. Kappa statistic will also be calculated for comparing the chance corrected agreement between various diagnostic methods.
Lesions diagnosed via non-invasive brush cytology
Time frame: Up to 10 years
Oral mucosa obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation will be compared to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression. Diagnostic methods will be compared with each other by forming 2x2 tables and computing the chi-square statistics for the McNemar test. Kappa statistic will also be calculated for comparing the chance corrected agreement between various diagnostic methods.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- 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 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 Cytology Specimen Collection Procedure, Diagnostic Microscopy and Diagnostic Procedure in people with Erythroplakia and Fanconi Anemia, 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 4 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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Lesions diagnosed via wide-field fluorescence imaging (time frame: Up to 10 years). The study lists 3 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 14 Sep 2026.