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Blue dye could make thyroid cancer surgery safer and more precise

NCT ID NCT07354698

Disease control Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether injecting a blue dye called mitoxantrone hydrochloride into the thyroid during robotic surgery helps surgeons see and remove cancer-affected lymph nodes while avoiding the parathyroid glands. 114 people with papillary thyroid cancer will be randomly assigned to get the dye or not. The goal is to see if the dye reduces accidental removal of parathyroid glands and improves lymph node removal.

What this could mean

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

Active substance
mitoxantrone hydrochloride injection (a blue dye used as a lymphatic tracer)
What this could lead to
If it works, this dye could help surgeons remove more cancer-affected lymph nodes while sparing healthy parathyroid glands, reducing complications like low calcium levels.
What could go wrong
This is a small, early-phase trial (114 people) testing a dye, not a treatment. The dye may not improve outcomes, and there are risks from the surgery itself and possible allergic reactions to the dye.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 114 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

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.

Ages

18 to 65 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 18-65 years old, both male and female; * Preoperative neck ultrasound and/or puncture pathology suggested thyroid cancer, and postoperative pathology diagnosed thyroid cancer (tumor diameter \<4cm); * There are no obvious contraindications to surgery during routine preoperative examination; * Meet the indications for thyroid lobe/total resection + unilateral/bilateral central lymph node dissection; * Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up. 4.2 Exclusion Criteria Exclusion Criteria: * Those who have a history of severe drug allergy or are allergic to the drugs in this study; * Those with serious primary diseases such as cardiovascular and cerebrovascular, liver, kidney, and hematological system; * Combined with parathyroid disease or other calcium and phosphorus metabolism-related diseases; * Benign thyroid lesions; * Received mitoxantrone treatment within 4 weeks; * Enrolled in other clinical studies at the same time; * Known history of psychotropic drug abuse, alcohol abuse or drug abuse; * Pregnant or lactating women; * According to the investigator's judgment, the subject has other factors that may cause him to be forced to terminate the study midway, such as suffering from other serious diseases (including mental illness) requiring combined treatment, serious abnormal laboratory examination values, family or social factors, which may affect the safety of the subject or the collection of trial data.

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Conditions

The condition(s) this trial relates to.

Thyroid Cancer, Papillary thyroid gland papillary carcinoma

As listed by the trial registrant

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

Papillary thyroid cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

  • Daping Hospital

    Chongqicun, 400042, China

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