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AI watches dye flow to predict cancer spread in thyroid surgery

NCT ID NCT07391514

Diagnosis Sponsor: First Affiliated Hospital of Chongqing 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether a computer program (deep learning) can predict if papillary thyroid cancer has spread to lymph nodes beyond the first draining node. During surgery, 131 adults with no signs of lymph node spread received injections of two dyes near the tumor. A camera recorded how the dyes moved through lymph nodes, and researchers analyzed the videos along with other medical data. The goal is to help surgeons decide how much tissue to remove, but the approach is still experimental.

What this could mean

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

Active substance
Indocyanine green (ICG) dye and carbon nanoparticles
What this could lead to
If successful, this could help surgeons decide how much tissue to remove during thyroid cancer surgery, potentially reducing unnecessary lymph node removal.
What could go wrong
This is a completed observational study with 131 participants, so results are preliminary. The computer predictions may not be accurate enough for routine use, and the technique requires special equipment and training.

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

131 people

The number who actually took part.

Started

Apr 2024

Finished

Oct 2024

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

Adults diagnosed with clinically node-negative papillary thyroid carcinoma (cN0-PTC) who are scheduled to undergo surgical treatment at the Department of Breast and Thyroid Surgery, First Affiliated Hospital of Chongqing Medical University, Chongqing, China. Participants are identified through routine clinical care and preoperative evaluation. The study population includes patients with primary PTC confirmed by fine-needle aspiration biopsy who have no evidence of lymph node metastasis on preoperative ultrasound or other imaging studies. Both male and female adults aged 18 years and older are eligible regardless of tumor size, location, or genetic mutation status.

Ages

18 years and older

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: 1. Age 18 years or older at the time of enrollment 2. Histologically confirmed papillary thyroid carcinoma (PTC) by preoperative fine-needle aspiration biopsy 3. Clinically node-negative (cN0) status confirmed by preoperative imaging (ultrasound and/or cross-sectional imaging showing no evidence of lymph node metastasis) 4. Scheduled to undergo thyroid surgery with simultaneous central lymph node dissection 5. Willing and able to provide written informed consent 6. Complete preoperative clinical data available, including: * Demographic information (age, sex, body mass index) * Thyroid ultrasound report with detailed tumor characteristics * Fine-needle aspiration biopsy pathology report * Genetic testing results (when available) 7. Able to undergo intraoperative dual-tracer sentinel lymph node mapping with near-infrared fluorescence video recording Exclusion Criteria: 1. History of previous neck surgery (including thyroid surgery, parathyroid surgery, or other cervical operations) 2. History of external beam radiotherapy to the head and neck region 3. Diagnosis of thyroid malignancy other than papillary thyroid carcinoma (e.g., follicular thyroid carcinoma, medullary thyroid carcinoma, anaplastic thyroid carcinoma, or thyroid lymphoma) 4. Known allergy or hypersensitivity to indocyanine green (ICG), iodine, or carbon nanoparticles 5. Severe hepatic insufficiency (ICG is metabolized by the liver) 6. Pregnancy or breastfeeding 7. Incomplete medical records or missing essential preoperative data 8. Refusal to undergo dual-tracer imaging procedure 9. Inability to obtain satisfactory intraoperative near-infrared fluorescence video recording due to technical issues or poor image quality 10. Participation in another interventional clinical trial that may interfere with the current study 11. Any condition that, in the investigator's opinion, would compromise the participant's safety or the quality of the study 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 carcinoma

Contacts and locations

Locations

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.