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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-10

Study Completion Date

2025-01-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Thyroid Gland Follicular Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Computed Tomography

Intervention Type PROCEDURE

Undergo a SPECT/CT scan

Iodine I-123

Intervention Type RADIATION

Given PO

Planar Imaging

Intervention Type PROCEDURE

Undergo planar imaging

Single Photon Emission Computed Tomography

Intervention Type PROCEDURE

Undergo a SPECT/CT scan

Interventions

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Computed Tomography

Undergo a SPECT/CT scan

Intervention Type PROCEDURE

Iodine I-123

Given PO

Intervention Type RADIATION

Planar Imaging

Undergo planar imaging

Intervention Type PROCEDURE

Single Photon Emission Computed Tomography

Undergo a SPECT/CT scan

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized Tomography CT CT Scan tomography I-123 Iodine 123 Iodine I 123 Isotope of Mass 123 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

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No