Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
NCT Number: NCT05591092
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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Notify Me18 year and older
All sexes
Observational
Rochester, Minnesota, 55905, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo a SPECT/CT scan
Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Given PO
Other names: I-123, Iodine 123, Iodine I 123, Isotope of Mass 123
Undergo planar imaging
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
Time frame: Up to study completion, up to one year
Adverse events will be assessed while patients are in the nuclear medicine division undergoing positron emission tomography/computed tomography imaging.
Time frame: Up to study completion; up to one year
We will compare the intensity of uptake in malignant versus benign lesions.
Mayo Clinic
Other
Radioiodine Scanning for Pre-Surgical Evaluation of Follicular Thyroid Nodules
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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