Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05591092 |
Other study ID # |
20-010663 |
Secondary ID |
NCI-2022-03573 |
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 5, 2021 |
Est. completion date |
May 1, 2025 |
Study information
Verified date |
October 2023 |
Source |
Mayo Clinic |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This phase II 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.
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 which were previously identified by
fine-needle aspiration (FNA) as indeterminate follicular neoplasms.
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 an 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.