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Can a glowing mouthwash spot oral cancer before biopsy?

NCT ID NCT07794813

Diagnosis Sponsor: Yunnan Cancer Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests a fluorescent probe called TTP-ICG that targets Trop2, a protein often found on oral cancer cells. Researchers will soak tissue samples from people with oral tumors in the probe and use near-infrared imaging to see if it can distinguish cancer from benign growths. They also plan to explore delivering the probe as a mouthwash, aiming for a less invasive and faster way to diagnose oral cancer. The study includes adults aged 18 to 75 who are scheduled for surgery for oral cancer or benign oral tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TTP-ICG incubation solution, a fluorescent probe that targets Trop2, a protein often found on oral cancer cells
What this could lead to
If it works, this could lead to a simple mouthwash-based imaging method that helps doctors detect oral cancer earlier and more accurately, reducing the need for invasive biopsies.
What could go wrong
This is an early-stage study with a small number of participants, and the probe's accuracy in real patients is still unproven. The mouthwash delivery method may not work as well as hoped, and the probe might not clearly distinguish cancer from benign growths.

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.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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.

Who is studied

The investigators plan to enroll 40 female patients, aged 18 to 75 years, who have been assessed to have resectable oral cancer or oral benign tumor and are scheduled to undergo surgery. During the surgery, the resected tumors will be incubated with the TTP-ICG solution, and NIR-II fluorescence signals from the tissues will be collected.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age range: 18-75 years old; * Patients with oral cancer or benign oral tumors who plan to undergo surgical intervention; * Preoperative coagulation function test was normal; ④ No serious underlying diseases; ⑤ WHO Physical Status Score 0-2 points; * Sign the informed consent form; Exclusion Criteria: * Suffering from other invasive malignant tumors; * Surgery cannot be performed for other serious illnesses; ③ Suffering from mental disorders and unable to sign informed consent forms on their own; * The subject requests to withdraw from the clinical trial; ⑤ The researchers believe that it is not appropriate for them to continue participating in this clinical trial.

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Conditions

The condition(s) this trial relates to.

disease oral cavity squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diagnosis Oral squamous cell carcinoma (OSCC)

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Yunnan Cancer Hospital

    RECRUITING

    Kunming, Yunnan, 650118, China

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