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A radioactive clue that could spare thousands from thyroid surgery

NCT ID NCT05591092

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial tests whether a special imaging scan using a small amount of radioactive iodine (iodine-123) can tell the difference between benign and cancerous thyroid nodules before surgery. Currently, biopsy alone can't always make that call, so many people undergo surgery just to find out. If the scan proves accurate, it could help doctors avoid unnecessary operations. The study involves adults with suspicious thyroid nodules who will receive the tracer and undergo planar and SPECT/CT imaging before their scheduled surgery.

What this could mean

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

Active substance
Iodine-123, a radioactive tracer used in imaging scans
What this could lead to
If successful, this imaging approach could help doctors identify cancerous thyroid nodules without surgery, sparing many patients from unnecessary operations.
What could go wrong
This is a very small early study, and the imaging may not reliably distinguish benign from malignant nodules. There is also a small radiation exposure risk from the tracer.

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

2 people

The number who actually took part.

Started

Nov 2023

Finished

Jan 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

Mayo Clinic patients with biopsy-proven indeterminate follicular thyroid lesions scheduled for surgery.

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 * Any gender * Patients will have had no therapy for their thyroid nodule prior to enrollment * Negative urine pregnancy test within 48 hours before the administration of radiopharmaceutical in women of childbearing potential * Follicular neoplasm or suspicious of follicular neoplasm, cytopathology on biopsy of thyroid nodule * Any outside fine needle aspiration (FNA) reports are to be reviewed by a Mayo pathologist * Nodules 1-4 cm with solid appearance on ultrasound * Ultrasound images and report documented in medical record, including the size of the nodule and location (upper, mid or lower portion of the thyroid lobe) * At least 2/3 of either thyroid lobe without nodules should be present to allow for the measurement of uptake in unaffected thyroid tissue * Thyroid stimulating hormone (TSH) 0.3-3.0 mIU/L * Patient is scheduled or being considered for surgical resection of the nodule * I-123 planar and Single Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT) can be scheduled at least 2 days after biopsy and before surgery Exclusion Criteria: * Recent iodinated contrast, including intravenous (IV) and oral CT contrast or interventional vascular or cardiac study (within 6 weeks) * Hurthle cell adenoma * Current thyroid hormone supplementation * Current use of anti-thyroid medications (methimazole or propylthiouracyl) * Less than 2 days after thyroid nodule FNA/biopsy * Presence of another nodule of similar size in the same area of thyroid lobe, which could impair localization of the nodule on SPECT/CT images * Less than 2/3 of normal thyroid tissue present in either thyroid lobe without nodules * Positive pregnancy test * All women who are breastfeeding

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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.

Contacts and locations

Locations

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

More trials for these conditions

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