Radioiodine Planar and a SPECT/CT Imaging With Iodine-123 for Evaluation of Follicular Thyroid Nodules Prior to Surgery
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-010663
NCT ID: NCT05591092
Sponsor Protocol Number: 20-010663
About this study
The objective of this study is to determine intensity of I-123 uptake in follicular thyroid lesions before surgery and correlate with final pathology findings.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 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) 0.3-2.0 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
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 07/03/2024. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available