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

Jena University Hospital

Status: Unknown

Conditions: Thyroid Diseases; Thyroid Nodule; Thyroid Goitre

Treatments: Other: Assessment of already preacquired I-124 PET/US

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03128255

I-124-04/2017

Details and patient eligibility

About

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

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 2 patient groups

Regular Thyroid Work-up

Description:

Nuclear Medicine physicians evaluate up to 34 cases of patients who have received regular thyroid diagnostics. Data and images of patient characteristics, laboratory results, ultrasonography loops and planar 99mTcO4 scintigraphy are provided and the physicians are asked to assign the function (hypo-, iso-, hyperfunctional) to predefined thyroid nodules visible on ultrasonography.

Regular Thyroid Work-up and I-124 PET/US

Description:

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.

Treatment:

Other: Assessment of already preacquired I-124 PET/US