Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03128255
Acronym
FUSION iENA
Enrollment
70
Registered
2017-04-25
Start date
2017-04-26
Completion date
2018-04-30
Last updated
2017-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Diseases, Thyroid Goitre, Thyroid Nodule

Keywords

Fusion, Hybrid Imaging, Mapping, Iodine, Ultrasound

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

Interventions

OTHERAssessment of already preacquired I-124 PET/US

Assessment of preacquired I-124 PET/US by review of anonymous digital case files

Sponsors

GE Healthcare
CollaboratorINDUSTRY
Jena University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Metabolic-sonographic nodule allocation1 yearThe 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.

Countries

Germany

Contacts

Primary ContactMartin Freesmeyer, Dr.med.
martin.freesmeyer@med.uni-jena.de+49 3641 9-329805
Backup ContactChristian Hollenbach
christian.hollenbach@med.uni-jena.de+49 3641 9-329805

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026