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

May 3, 2017 updated by: Jena University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Data of patients with unclear findings on regular thyroid work-up who had received additional I-124-PET/US in our institution.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Regular Thyroid Work-up
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
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.
Other: Assessment of already preacquired I-124 PET/US
Assessment of preacquired I-124 PET/US by review of anonymous digital case files

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic-sonographic nodule allocation
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jena University Hospital

Collaborators

GE Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2017

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

April 20, 2017

First Submitted That Met QC Criteria

April 24, 2017

First Posted (Actual)

April 25, 2017

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-124-04/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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