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 range18 Years

SexALL

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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…

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