Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-30 @ 5:06 AM
Study NCT ID:
NCT05591092
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2022-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radioiodine Planar and a SPECT/CT Imaging With Iodine-123 for Evaluation of Follicular Thyroid Nodules Prior to Surgery
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Radioiodine Scanning for Pre-Surgical Evaluation of Follicular Thyroid Nodules
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-03573 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |