Head and Neck CancerPhase 1NCT02251639
Diagnostic Aids for Detection and Diagnosis of Oral Cancer
A Phase 1 study testing Questionnaire, POS + PS2 + VELscope and Oral Brush Biopsy in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical study is to find out if certain instruments/devices, such as wide field fluorescence imaging point spectroscopy and/or brush cytology, can help health care providers find mouth cancer more quickly than a standard oral clinical exam. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Questionnaire, POS + PS2 + VELscope and Oral Brush Biopsy
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Oct 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects 18 years and older who are willing to participate.
- Persons presenting for: Physical or dental exams at outside health care centers OR Research meetings/gatherings OR Subjects identified at MDACC who are not already diagnosed with oral cancer or pre oral cancer: this includes patients with malignancies other than oral cancer, and visitors and family members, attendees of the HNS Oral Cancer Screening event who are willing to participate.
Who cannot join
- Subjects with a current diagnosis of oral cancer.
- Subjects under the age of 18. It is extremely unusual for children to develop oral cancer, therefore data from persons younger than 18 may add unexpected variables which could affect data analysis.
- Subjects who are unable or unwilling to give informed consent.
About this study
Official title: Evaluation of Diagnostic Aids for Detection and Diagnosis of Oral Cancer
The goal of this clinical study is to find out if certain instruments/devices, such as wide field fluorescence imaging point spectroscopy and/or brush cytology, can help health care providers find mouth cancer more quickly than a standard oral clinical exam.
Read the detailed description
Study Procedures:
Certain types of light may cause cells to give off a tiny amount of light (called fluorescence). Researchers have learned that cancer cells and normal cells reflect light and give off fluorescence differently. Researchers want to find out if different kinds of light can be used to discover areas of the mouth that may have abnormal or cancerous cells.
If you agree to take part in this study, a researcher may use up to 3 types of imaging instruments to take pictures and readings of several areas in your mouth.
- VELScope is an FDA approved handheld camera device that takes images of the mouth with different colors of light. The VELScope shines blue light into the mouth, and pictures are taken using a camera that is attached to the device.
- Widefield Fluorescence Imaging uses a non-contact imaging device similar to the VELScope. It shines different colors of light and then takes pictures of the inside of the mouth using a digital camera.
- Point Spectroscopy System uses a probe (about the size of a tip of a pen) that is gently placed on several areas of the mouth. Different colors of light are directed through optic fibers to the lining of the mouth, and the probe collects the light that returns from the tissue and sends the information to a computer.
Researchers will record whether the doctors find any areas within your mouth that may not appear completely normal. They will collect tissue samples of these abnormal areas using a brush biopsy. To perform an oral brush biopsy, the research will press a small brush against an area inside your mouth, and turn it 5-10 times. The areas that could be biopsied include your gums, tongue, the roof of your mouth, the bottom of your mouth, or the inside of your cheeks. Any cells collected from the inside of your mouth will be placed on slides to be studied by the study team.
The samples being collected will only be used for this testing, and no leftover samples will be kept by the research staff.
These procedures should take about 20 minutes total.
This is an investigational study. The VELScope is an FDA approved device and is commercially available. Wide-field and point spectroscopy systems are not FDA approved and are only authorized for research. Up to 500 participants will take part in this multicenter study. Up to 250 will be enrolled at MD Anderson.
- Conditions
- Head and Neck Cancer
- Being tested
- Questionnaire, POS + PS2 + VELscope, Oral Brush Biopsy
- Keywords
- Oral cancer, Pre-cancer, Widefield Fluorescence Imaging, VELScope, Point Spectroscopy System, Oral brush biopsy, Questionnaire, Survey, Diagnostic aid, Screening
- Medical subject headings
- Head and Neck Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Participant completes a short questionnaire regarding their awareness of oral cancer and risk factors.
POS + PS2 + VELscopeDevice
Oral cavity examined with one or more of the widefield imaging devices, such as the VELscope and/or PS2 device.
Oral Brush BiopsyProcedure or surgery
If abnormal areas found, a small brush is pressed against an area inside mouth, and turned 5-10 times. The areas that could be biopsied include gums, tongue, roof of mouth, bottom of mouth, or the inside of cheeks.
| Study group | Role | What they receive |
|---|---|---|
| Oral Imaging and Cytology | Experimental | Participant completes a short questionnaire regarding their awareness of oral cancer and risk factors. Oral cavity inspected using a standard white light headlamp. Oral cavity then examined with one or more of the widefield imaging devices, such as the VELscope and/or PS2 device. Exfoliative cells for cytology from an abnormal area (if present) and from a contralateral normal appearing area obtained using a brush. Receives: Behavioral: Questionnaire; Device: POS + PS2 + VELscope; Procedure: Oral Brush Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the POS, PS2 and VELscope as Diagnostic Aid for Oral Cancer
Information obtained from the fluorescence and reflectance images, point spectroscopy, and oral cytology compared with clinical diagnosis to evaluate the performance of the diagnostic aids and assess any clinical benefit to assist in screening for oral cancer. ROC curve analysis used as primary method for evaluating the performance of the POS, PS2 and VELscope devices as compared to the white light standard clinical diagnosis.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: Study design improvements.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), William Marsh Rice University
- Responsible party
- Sponsor
- Investigators
- Ann M. Gillenwater, MD, BA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251639
- Sponsor's protocol ID
- 2012-0887
- Other IDs
- NCI-2014-02105, RO1 910576, 960113
- Status last verified
- Apr 2017
- First submitted
- 23 Sep 2014
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Aids for Detection and Diagnosis of Oral Cancer
- ClinicalTrials.gov ID
- NCT02251639
- Acronym / sponsor ID
- 2012-0887
- Conditions
- Head and Neck Cancer
- Keywords
- Oral cancer, Pre-cancer, Widefield Fluorescence Imaging, VELScope, Point Spectroscopy System, Oral brush biopsy, Questionnaire, Survey
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study design improvements.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), William Marsh Rice University
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 29 Sep 2014 (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 study is to find out if certain instruments/devices, such as wide field fluorescence imaging point spectroscopy and/or brush cytology, can help health care providers find mouth cancer more quickly than a standard oral clinical exam.
Detailed description
Study Procedures:
Certain types of light may cause cells to give off a tiny amount of light (called fluorescence). Researchers have learned that cancer cells and normal cells reflect light and give off fluorescence differently. Researchers want to find out if different kinds of light can be used to discover areas of the mouth that may have abnormal or cancerous cells.
If you agree to take part in this study, a researcher may use up to 3 types of imaging instruments to take pictures and readings of several areas in your mouth.
- VELScope is an FDA approved handheld camera device that takes images of the mouth with different colors of light. The VELScope shines blue light into the mouth, and pictures are taken using a camera that is attached to the device.
- Widefield Fluorescence Imaging uses a non-contact imaging device similar to the VELScope. It shines different colors of light and then takes pictures of the inside of the mouth using a digital camera.
- Point Spectroscopy System uses a probe (about the size of a tip of a pen) that is gently placed on several areas of the mouth. Different colors of light are directed through optic fibers to the lining of the mouth, and the probe collects the light that returns from the tissue and sends the information to a computer.
Researchers will record whether the doctors find any areas within your mouth that may not appear completely normal. They will collect tissue samples of these abnormal areas using a brush biopsy. To perform an oral brush biopsy, the research will press a small brush against an area inside your mouth, and turn it 5-10 times. The areas that could be biopsied include your gums, tongue, the roof of your mouth, the bottom of your mouth, or the inside of your cheeks. Any cells collected from the inside of your mouth will be placed on slides to be studied by the study team.
The samples being collected will only be used for this testing, and no leftover samples will be kept by the research staff.
These procedures should take about 20 minutes total.
This is an investigational study. The VELScope is an FDA approved device and is commercially available. Wide-field and point spectroscopy systems are not FDA approved and are only authorized for research. Up to 500 participants will take part in this multicenter study. Up to 250 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 |
|---|---|---|
| Oral Imaging and Cytology | Experimental | Behavioral: Questionnaire, Device: POS + PS2 + VELscope, Procedure: Oral Brush BiopsyParticipant completes a short questionnaire regarding their awareness of oral cancer and risk factors. Oral cavity inspected using a standard white light headlamp. Oral cavity then examined with one or more of the widefield imaging devices, such as the VELscope and/or PS2 device. Exfoliative cells for cytology from an abnormal area (if present) and from a contralateral normal appearing area obtained using a brush. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects 18 years and older who are willing to participate.
- Persons presenting for: Physical or dental exams at outside health care centers OR Research meetings/gatherings OR Subjects identified at MDACC who are not already diagnosed with oral cancer or pre oral cancer: this includes patients with malignancies other than oral cancer, and visitors and family members, attendees of the HNS Oral Cancer Screening event who are willing to participate.
Key exclusion criteria (3 listed)
- Subjects with a current diagnosis of oral cancer.
- Subjects under the age of 18. It is extremely unusual for children to develop oral cancer, therefore data from persons younger than 18 may add unexpected variables which could affect data analysis.
- Subjects who 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 |
|---|---|---|
| QuestionnaireAlso: SurveyParticipant completes a short questionnaire regarding their awareness of oral cancer and risk factors. | Behavioural | Oral Imaging and Cytology |
| POS + PS2 + VELscopeOral cavity examined with one or more of the widefield imaging devices, such as the VELscope and/or PS2 device. | Device | Oral Imaging and Cytology |
| Oral Brush BiopsyIf abnormal areas found, a small brush is pressed against an area inside mouth, and turned 5-10 times. The areas that could be biopsied include gums, tongue, roof of mouth, bottom of mouth, or the inside of cheeks. | Procedure or surgery | Oral Imaging and Cytology |
Primary outcome
Performance of the POS, PS2 and VELscope as Diagnostic Aid for Oral Cancer
Time frame: 1 day
Information obtained from the fluorescence and reflectance images, point spectroscopy, and oral cytology compared with clinical diagnosis to evaluate the performance of the diagnostic aids and assess any clinical benefit to assist in screening for oral cancer. ROC curve analysis used as primary method for evaluating the performance of the POS, PS2 and VELscope devices as compared to the white light standard clinical diagnosis.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 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, BA principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Questionnaire, POS + PS2 + VELscope and Oral Brush Biopsy in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center.
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 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: withdrawn, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Performance of the POS, PS2 and VELscope as Diagnostic Aid for Oral Cancer (time frame: 1 day). 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 27 Apr 2017.