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

NCT05591092 | Completed

• 2 other identifiers: 20-010663NCI-2022-03573
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Gland Follicular Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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; Radiation: Iodine I-123; Procedure: Planar Imaging; Procedure: Single Photon Emission Computed Tomography

Interventions

Computed Tomography PROCEDURE

Undergo a SPECT/CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Observational (I-123, planar imaging, SPECT/CT scan)

Iodine I-123 RADIATION

Given PO

Also known as: I-123, Iodine 123, Iodine I 123, Isotope of Mass 123

Observational (I-123, planar imaging, SPECT/CT scan)

Planar Imaging PROCEDURE

Undergo planar imaging

Observational (I-123, planar imaging, SPECT/CT scan)

Single Photon Emission Computed Tomography PROCEDURE

Undergo a SPECT/CT scan

Also known as: 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

Observational (I-123, planar imaging, SPECT/CT scan)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Adenocarcinoma, Follicular

Interventions

Iodine-123; X-Rays; Photons

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Elementary Particles; Light; Optical Phenomena; Radiation, Nonionizing

Study Officials

• Jolanta M. Durski, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 24, 2022
• Study Start: November 10, 2023
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

US (1)