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Trial Title:
Radioiodine Planar and a SPECT/CT Imaging with Iodine-123 for Evaluation of Follicular Thyroid Nodules Prior to Surgery
NCT ID:
NCT05591092
Condition:
Thyroid Gland Follicular Carcinoma
Conditions: Official terms:
Thyroid Nodule
Adenocarcinoma, Follicular
Thyroid Diseases
Iodine
Cadexomer iodine
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo a SPECT/CT scan
Arm group label:
Observational (I-123, planar imaging, SPECT/CT scan)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Radiation
Intervention name:
Iodine I-123
Description:
Given PO
Arm group label:
Observational (I-123, planar imaging, SPECT/CT scan)
Other name:
I-123
Other name:
Iodine 123
Other name:
Iodine I 123
Other name:
Isotope of Mass 123
Intervention type:
Procedure
Intervention name:
Planar Imaging
Description:
Undergo planar imaging
Arm group label:
Observational (I-123, planar imaging, SPECT/CT scan)
Intervention type:
Procedure
Intervention name:
Single Photon Emission Computed Tomography
Description:
Undergo a SPECT/CT scan
Arm group label:
Observational (I-123, planar imaging, SPECT/CT scan)
Other name:
Medical Imaging, Single Photon Emission Computed Tomography
Other name:
Single Photon Emission Tomography
Other name:
single-photon emission computed tomography
Other name:
SPECT
Other name:
SPECT imaging
Other name:
SPECT SCAN
Other name:
SPET
Other name:
tomography, emission computed, single photon
Other name:
Tomography, Emission-Computed, Single-Photon
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.
Criteria for eligibility:
Study pop:
Mayo Clinic patients with biopsy-proven indeterminate follicular thyroid lesions
scheduled for surgery.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Jolanta M. Durski, MD
Start date:
November 10, 2023
Completion date:
November 30, 2026
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05591092
https://www.mayo.edu/research/clinical-trials
