Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT05591092
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05591092
Study Brief:
Protocol Section:
NCT05591092