Oral TumorsNCT00502125
In Vivo Confocal Imaging of Oral Mucosa
An observational study of Oral Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The objective of this study is to evaluate the feasibility of using reflectance confocal imaging to noninvasively detect and diagnose oral dysplasia and early carcinoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Tumors
- What is being tested?
- Reflectance Confocal Imaging
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Sep 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with oral lesions.
Who may be able to join
- Patients with oral lesions who give informed consent to participate in the study.
- Any person with an oral lesion, particularly those suspicious for dysplasia or carcinoma.
Who cannot join
- Lack of any oral mucosal lesions
- Oral lesions not physically accessible for probe placement or biopsy
- Unwillingness to tolerate probe placement, dilute acetic acid rinse or biopsy
- Unwillingness to provide informed consent
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
Official title: A Pilot Study: In Vivo Reflectance Confocal Imaging for Detection of Neoplasia of Oral Mucosa
The objective of this study is to evaluate the feasibility of using reflectance confocal imaging to noninvasively detect and diagnose oral dysplasia and early carcinoma.
Read the detailed description
The study will take place at M. D. Anderson. Examinations will be performed in the cancer prevention, head and neck or dental clinics, or the operating room for patients who get scheduled for surgery as part of their standard care.
Abnormal looking areas (lesions) inside the mouth may be a sign of cancer or changes that may lead to cancer. Researchers are looking for a practical way to tell early on whether these lesions are cancer or may become cancer. This study will look at a technique called reflectance confocal imaging.
Participants in this study will have an examination of the mouth. A photograph will be taken of any abnormal areas inside the mouth. Then a small probe, about the size of a large ink pen, will be placed gently against one to two abnormal appearing areas, and one normal appearing area inside the mouth. The probe will expose the oral lining to a small amount of light. Some of this light will be reflected back into the probe, and be picked up by a computer. Pictures will be made of the tissue.
A small amount of vinegar will be placed at each site with a cotton swab before the probe is placed. The procedure takes about 1-2 minutes at each site. A small sample of tissue from each site, both the normal and abnormal, will be removed. The biopsies done on the normal tissue are done for this study only and are not part of standard care. The samples will be removed either at the time of surgery or under local anesthesia in the clinic. Briefly, the small areas to be biopsied will be numbed with topical anesthesia and an injection of local anesthesia. Then a small amount of tissue, about as big as a pencil eraser, will be removed with sterile surgical instruments. This should cause little discomfort or bleeding. The tissue will be placed in a special fluid and then looked at with a special microscope. The tissue samples will be examined with a microscope by a pathologist to learn if the tissue is cancerous or precancerous. These results will be compared with the pictures that were made of the lining of the mouth.
You will not be told of any of the experimental findings. The pathology review of the tissue removed will be available to the treating physician for patient care.
THIS IS AN INVESTIGATIONAL STUDY. The device used for reflectance confocal imaging is an investigational device. It is considered a non-significant risk device by the FDA to be used for research only. A total of 22 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Oral Tumors
- Being tested
- Reflectance Confocal Imaging
- Keywords
- Reflectance Confocal Imaging, Oral Mucosal Lesions, Oral Mucosa Disease, Neoplasia Detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflectance Confocal ImagingProcedure or surgery
A photograph will be taken of any abnormal areas inside the mouth. A small probe will expose the oral lining to a small amount of light. Some of this light will be reflected back into the probe, and be picked up by a computer. Pictures will be made of the tissue.
| Study group | Role | What they receive |
|---|---|---|
| Patients with oral lesions | Not described Receives: Procedure: Reflectance Confocal Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study if using reflectance confocal imaging can detect and diagnose abnormal growths in the mouth and early cancer.
Measured: 6 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 startJan 2003
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral TumorsStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Ann M. Gillenwater, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502125
- Sponsor's protocol ID
- ID02-494
- Status last verified
- Jul 2012
- First submitted
- 13 Jul 2007
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: In Vivo Reflectance Confocal Imaging for Detection of Neoplasia of Oral Mucosa
- ClinicalTrials.gov ID
- NCT00502125
- Acronym / sponsor ID
- ID02-494
- Conditions
- Oral Tumors
- Keywords
- Reflectance Confocal Imaging, Oral Mucosal Lesions, Oral Mucosa Disease, Neoplasia Detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2003
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (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.
The objective of this study is to evaluate the feasibility of using reflectance confocal imaging to noninvasively detect and diagnose oral dysplasia and early carcinoma.
Detailed description
The study will take place at M. D. Anderson. Examinations will be performed in the cancer prevention, head and neck or dental clinics, or the operating room for patients who get scheduled for surgery as part of their standard care.
Abnormal looking areas (lesions) inside the mouth may be a sign of cancer or changes that may lead to cancer. Researchers are looking for a practical way to tell early on whether these lesions are cancer or may become cancer. This study will look at a technique called reflectance confocal imaging.
Participants in this study will have an examination of the mouth. A photograph will be taken of any abnormal areas inside the mouth. Then a small probe, about the size of a large ink pen, will be placed gently against one to two abnormal appearing areas, and one normal appearing area inside the mouth. The probe will expose the oral lining to a small amount of light. Some of this light will be reflected back into the probe, and be picked up by a computer. Pictures will be made of the tissue.
A small amount of vinegar will be placed at each site with a cotton swab before the probe is placed. The procedure takes about 1-2 minutes at each site. A small sample of tissue from each site, both the normal and abnormal, will be removed. The biopsies done on the normal tissue are done for this study only and are not part of standard care. The samples will be removed either at the time of surgery or under local anesthesia in the clinic. Briefly, the small areas to be biopsied will be numbed with topical anesthesia and an injection of local anesthesia. Then a small amount of tissue, about as big as a pencil eraser, will be removed with sterile surgical instruments. This should cause little discomfort or bleeding. The tissue will be placed in a special fluid and then looked at with a special microscope. The tissue samples will be examined with a microscope by a pathologist to learn if the tissue is cancerous or precancerous. These results will be compared with the pictures that were made of the lining of the mouth.
You will not be told of any of the experimental findings. The pathology review of the tissue removed will be available to the treating physician for patient care.
THIS IS AN INVESTIGATIONAL STUDY. The device used for reflectance confocal imaging is an investigational device. It is considered a non-significant risk device by the FDA to be used for research only. A total of 22 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 |
|---|---|---|
| Patients with oral lesions | – | Procedure: Reflectance Confocal Imaging |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with oral lesions.
Key inclusion criteria (2 listed)
- Patients with oral lesions who give informed consent to participate in the study.
- Any person with an oral lesion, particularly those suspicious for dysplasia or carcinoma.
Key exclusion criteria (4 listed)
- Lack of any oral mucosal lesions
- Oral lesions not physically accessible for probe placement or biopsy
- Unwillingness to tolerate probe placement, dilute acetic acid rinse or biopsy
- Unwillingness to provide 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 |
|---|---|---|
| Reflectance Confocal ImagingA photograph will be taken of any abnormal areas inside the mouth. A small probe will expose the oral lining to a small amount of light. Some of this light will be reflected back into the probe, and be picked up by a computer. Pictures will be made of the tissue. | Procedure or surgery | Patients with oral lesions |
Primary outcome
To study if using reflectance confocal imaging can detect and diagnose abnormal growths in the mouth and early cancer.
Time frame: 6 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 1 Aug 2012.
- The University of Texas M.D.Anderson Cancer CenterLink 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 Tumors, 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 2 inclusion and 4 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 1 Aug 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?
To study if using reflectance confocal imaging can detect and diagnose abnormal growths in the mouth and early cancer. (time frame: 6 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 1 Aug 2012.