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

Radioiodine Scanning for Pre-Surgical Evaluation of Follicular Thyroid Nodules

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Gland Follicular Carcinoma
• Intervention / Treatment: Procedure: Computed Tomography; Radiation: Iodine I-123; Procedure: Planar Imaging; Procedure: Single Photon Emission Computed Tomography

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the proportion of benign nodules appearing as hot/warm on radioiodine scans (nodule uptake >= uptake in normal thyroid tissues).

II. To identify a possible relationship between iodine-123 (I-123) uptake on planar and single-photon emission computerized tomography (SPECT)/computerized tomography (CT) images and malignancy on surgical pathology in thyroid nodules that were previously identified by fine-needle aspiration (FNA) as indeterminate follicular neoplasm.

III. Examine correlations between intensity of uptake in follicular nodules before surgery (standard uptake values [SUV] on the quantitative reconstructions from our Veriton SPECT/CT scanner and nodule-to-normal thyroid background ratios on planar and SPECT images) and pathology findings and determine a SUV threshold that best distinguishes between benign and malignant nodules.

IV. Compare the usefulness of conventional planar imaging versus SPECT/CT imaging for thyroid nodules, in order to inform our optimal clinical protocol.

V. Establish an imaging protocol best suited for measuring uptake in small thyroid nodules.

OUTLINE:

Patients receive iodine-123 orally (PO) and then undergo planar imaging and a SPECT/CT scan on study.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational (I-123, planar imaging, SPECT/CT scan); Patients receive iodine-123 PO and then undergo planar imaging and a SPECT/CT scan on study.

Procedure: Computed Tomography; Undergo a SPECT/CT scan; Other Names: CT; CAT; CAT Scan; Computed Axial Tomography; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Radiation: Iodine I-123; Given PO; Other Names: I-123; Iodine 123; Iodine I 123; Isotope of Mass 123; Procedure: Planar Imaging; Undergo planar imaging; Procedure: Single Photon Emission Computed Tomography; Undergo a SPECT/CT scan; Other Names: Medical Imaging, Single Photon Emission Computed Tomography; Single Photon Emission Tomography; single-photon emission computed tomography; SPECT; SPECT imaging; SPECT SCAN; SPET; tomography, emission computed, single photon; Tomography, Emission-Computed, Single-Photon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Adverse events will be assessed while patients are in the nuclear medicine division undergoing positron emission tomography/computed tomography imaging.	Up to study completion, up to one year
Iodine-123 uptake	We will compare the intensity of uptake in malignant versus benign lesions.	Up to study completion; up to one year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Jolanta M. Durski, MD, Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Actual): January 21, 2025
• Study Completion (Actual): January 21, 2025

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Thyroid Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Thyroid Diseases; Thyroid Nodule; Adenocarcinoma, Follicular; Anti-Infective Agents; Physiological Effects of Drugs; Trace Elements; Micronutrients; Anti-Infective Agents, Local; Iodine; Cadexomer iodine
• Other Study ID Numbers: 20-010663; NCI-2022-03573 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No