Fusion UltraSound Imaging Of the Thyroid GlaNd With I-124 PET. Evaluation of Nodule Allocation.

• Conditions: Thyroid Goitre; Thyroid Nodule; Thyroid Diseases
• Interventions: Other: Assessment of already preacquired I-124 PET/US

• Registration Number: NCT03128255
• Lead Sponsor: Jena University Hospital

Brief Summary

Regular thyroid diagnostics versus augmented thyroid work-up with additional I-124 PET/US fusion for metabolic-sonographic nodule allocation in patients with benign thyroid diseases

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-25
• Study Start: 2017-04-26
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-04
• Primary Completion: 2017-07
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• patients with thyroidal nodules,
• euthyroidism
• Uptake >0,5% on Tc-99m-pertechnetate- scintigraphy

Exclusion Criteria

• thyroid medications in the last 6 months
• Iodine exposition in the last 6 months
• thyroid surgery or radioiodine therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Regular Thyroid Work-up and I-124 PET/US	Assessment of already preacquired I-124 PET/US	Nuclear Medicine physicians evaluate up to 34 cases of patients who have received regular thyroid diagnostics and additional I-124 PET/CT, followed by I-124 PET/US (administration of I-124 was not subject of this study). Data and images of patient characteristics, laboratory results, ultrasonography loops, planar 99mTcO4 scintigraphy as well as I-124 PET/US loops are provided and the physicians are asked to assign the function (hypo-, iso-, hyperfunctional) to predefined thyroid nodules visible on ultrasonography.

Primary Outcome Measures

Name	Time	Method
Metabolic-sonographic nodule allocation	1 year	The number of correct assignments of metabolic function of each nodule will be assessed for each group seperately. A three-point scale will be used for evaluation of the nodule's function and the degree of the physicians certainty will be investigated using a four-point scale.

Trial Locations

Locations (1)

University Hospital Jena; 🇩🇪 Jena, Thuringia, Germany