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NCT03128255 Clinical Trial

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

Thyroid Nodule Clinical Trial

— FUSION iENA  

Official title:
I-124 PET/US for Benign Thyroid Diseases - Blinded, Multicentric Assessment of Augmented Thyroid Work-up Versus Regular Thyroid Diagnostics

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03128255
Other study ID # I-124-04/2017
Secondary ID
Status Recruiting
Phase N/A
First received April 20, 2017
Last updated May 3, 2017
Start date April 26, 2017
Est. completion date April 2018

Study information
Verified date April 2017
Source Jena University Hospital
Contact Martin Freesmeyer, Dr.med.
Phone +49 3641 9-329805
Email martin.freesmeyer@med.uni-jena.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date April 2018
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Assessment of already preacquired I-124 PET/US
Assessment of preacquired I-124 PET/US by review of anonymous digital case files

Locations
Country Name City State
Germany University Hospital Jena Jena Thuringia

Sponsors (2)
Lead Sponsor Collaborator
Jena University Hospital GE Healthcare

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Metabolic-sonographic nodule allocation 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. 1 year
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