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

NCT03128255 | Unknown

• 1 other identifier: I-124-04/2017
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Thyroid Nodule; Thyroid Diseases; Thyroid Goitre

Keywords

Fusion; Hybrid Imaging; Mapping; Iodine; Ultrasound

Outcome Measures

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.

  1 year

Study Arms (2)

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

Assessment of already preacquired I-124 PET/US OTHER

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jena University Hospital: lead
• GE Healthcare: collaborator

Study Sites (1)

University Hospital Jena

Jena, Thuringia, 07747, Germany

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule; Thyroid Diseases; Goiter

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases

Central Study Contacts

Martin Freesmeyer, Dr.med.

CONTACT

+49 3641 9-329805; martin.freesmeyer@med.uni-jena.de

Christian Hollenbach

CONTACT

+49 3641 9-329805; christian.hollenbach@med.uni-jena.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 25, 2017
• Study Start: April 26, 2017
• Primary Completion: July 1, 2017
• Study Completion: April 1, 2018
• Last Updated: May 4, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)