CClinicalTrials.gg
Status unknownNCT03128255FUSION iENAUpdated May 4, 2017

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

An observational study in Thyroid Nodule, Thyroid Diseases and Thyroid Goitre, sponsored by Jena University Hospital. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-04.

Sponsored by Jena University Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
70
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Thyroid Nodule
  • Thyroid Diseases
  • Thyroid Goitre

Keywords

  • Fusion
  • Hybrid Imaging
  • Mapping
  • Iodine
  • Ultrasound
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • thyroid medications in the last 6 months
  • Iodine exposition in the last 6 months
  • thyroid surgery or radioiodine therapy
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherAssessment of already preacquired I-124 PET/US

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03128255
Lead sponsor
Jena University Hospital
Collaborators
GE Healthcare
Responsible party
Sponsor
First posted
Apr 25, 2017
Start date
Apr 26, 2017
Primary completion
Jul 2017 (estimated)
Completion
Apr 2018 (estimated)
Last update
May 4, 2017

Study contacts

Martin Freesmeyer, Dr.med.
Contact
martin.freesmeyer@med.uni-jena.de
+49 3641 9-329805
Christian Hollenbach
Contact
christian.hollenbach@med.uni-jena.de
+49 3641 9-329805

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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