CompletedNot Applicable

Radioiodine Planar and a SPECT/CT Imaging With Iodine-123 for Evaluation of Follicular Thyroid Nodules Prior to Surgery

United States2 participantsStarted 2023-11-10

Plain-language summary

This study evaluates radioiodine planar and SPECT/CT imaging with iodine-123 in patients with follicular thyroid nodules prior to surgery. Because biopsy alone is not sufficient to distinguish between malignant follicular thyroid nodules and benign follicular thyroid nodules, patients with follicular thyroid lesions are referred for surgery for further evaluation. A non-invasive imaging method that can accurately determine malignancy in follicular thyroid nodules would be valuable in patient management and could potentially spare patients unnecessary surgery. Planar imagine uses a gamma camera to obtain 2D images and SPECT/CT imaging is a special type of CT scan in which a small amount of a radioactive drug is injected into a vein and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the tumor cells. Radioiodine planar and SPECT/CT imaging may be more accurate in distinguishing between benign follicular thyroid nodules and malignant follicular thyroid nodules to help reduce the need for surgery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 i…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of adverse events

Timeframe: Up to study completion, up to one year

Iodine-123 uptake

Timeframe: Up to study completion; up to one year

Trial details

NCT IDNCT05591092

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-21

View on ClinicalTrials.gov More Thyroid Gland Follicular Carcinoma trials