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Real-Time tissue test may help surgeons avoid unnecessary neck dissections in thyroid cancer

NCT ID NCT07659717

Knowledge-focused Sponsor: Eleonora Lori, MD 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested whether a rapid lab test called frozen section analysis, done during thyroid surgery, can help surgeons decide how many lymph nodes to remove from the neck. The study included 66 adults with low-risk thyroid cancer and no signs of spread before surgery. The goal was to see if this approach could reduce unnecessary surgery while still removing enough tissue to control the disease.

What this could mean

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

Active substance
Frozen section analysis (a rapid lab test on tissue removed during surgery)
What this could lead to
If successful, this approach could help surgeons tailor the extent of neck surgery in real time, potentially reducing unnecessary procedures and complications.
What could go wrong
This is a small pilot study (66 participants) with no long-term follow-up on cancer recurrence. The findings may not apply to all thyroid cancer patients.

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

66 people

The number who actually took part.

Started

Jan 2023

Finished

Sep 2025

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 study population includes consecutive adult patients treated in a tertiary referral endocrine surgery unit who underwent primary thyroid surgery for cytologically suspicious or malignant thyroid nodules. Eligible patients had Bethesda V or VI thyroid cytology, a solitary low-risk thyroid nodule smaller than 2.5 cm, and a clinically node-negative neck documented by preoperative cervical ultrasound. All patients were managed according to institutional surgical protocols and had prospectively collected clinical, surgical, and histopathological data available for analysis.

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: * age 18 years or older. * Adult patients undergoing primary thyroid surgery. * Preoperative thyroid cytology classified as Bethesda V or Bethesda VI according to the Bethesda System for Reporting Thyroid Cytopathology. * Presence of a solitary thyroid nodule. * Maximum nodule diameter less than 2.5 cm. * Low-risk thyroid nodule according to clinical, cytological, and ultrasound criteria. * Clinically node-negative neck, documented by preoperative cervical ultrasound. * Availability of complete histopathological report for the thyroid specimen. * Availability of complete histopathological report for central compartment lymph nodes, when removed. * Written informed consent for surgery and for the use of clinical and pathological data for research purposes. Exclusion Criteria: * Age younger than 18 years. * Previous thyroid or neck surgery, including completion thyroidectomy or secondary lymph node dissection * Known cervical lymph node metastases or distant metastases at the time of surgery. * Thyroid nodule measuring 2.5 cm or more in maximum diameter. * Incomplete clinical and pathological data relevant to the study endpoints.

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Conditions

The condition(s) this trial relates to.

Lymphatic Metastasis metastatic malignant neoplasm in the lymph nodes Thyroid Cancer, Papillary thyroid gland papillary carcinoma

As listed by the trial registrant

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

Lymph node metastasis Papillary thyroid cancer

Contacts and locations

Locations

  • Policlinico "P. Giaccone" University of Palermo

    Palermo, Sicily, 90127, Italy

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