Could a simple dye and camera detect mouth cancer early?
NCT ID NCT01269190
First seen Jun 24, 2026 · Last updated Jul 30, 2026 · Updated 5 times
Summary
This study tests whether a special camera and a fluorescent dye called proflavine can help doctors see abnormal cells in the mouth. Researchers will take images of mouth lesions from 275 adults who are already scheduled for surgery. The goal is to see if this non-invasive method can tell the difference between normal tissue, pre-cancer, and cancer, potentially reducing the need for biopsies in the future.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Proflavine (a fluorescent dye applied to mouth tissue)
- What this could lead to
- If successful, this could lead to a non-invasive way to detect oral pre-cancer and cancer during a routine exam, reducing the need for biopsies.
- What could go wrong
- This is an early feasibility study, so the imaging method may not be accurate enough to replace standard biopsy. The dye may also cause allergic reactions in some people.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 275 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2010
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult subjects with oral lesions undergoing surgical resection (i.e., only patients who are scheduled to undergo a surgery of the head \& neck area to remove or biopsy oral lesions will be eligible to participate in the study); patients with previous treatment are eligible * Ability to understand and the willingness to sign a written informed consent document (ICD) Exclusion Criteria: * Known allergy to proflavine or acriflavine * Pregnant or nursing females * The participant will be excluded from participation in another clinical research trial (i.e., a trial in which an agent is actively administered to the study subject), while being imaged (on active treatment) on this protocol
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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