Thyroid NoduleFUSION iENANCT03128255
Fusion UltraSound Imaging Of the Thyroid GlaNd With I-124 PET. Evaluation of Nodule Allocation.
An observational study of Thyroid Nodule and Thyroid Diseases, run by Jena University Hospital at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule, Thyroid Diseases, Thyroid Goitre
- What is being tested?
- Assessment of already preacquired I-124 PET/US
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 26 Apr 2017to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data of patients with unclear findings on regular thyroid work-up who had received additional I-124-PET/US in our institution.
Who may be able to join
- patients with thyroidal nodules,
- euthyroidism
- Uptake >0,5% on Tc-99m-pertechnetate- scintigraphy
Who cannot join
- thyroid medications in the last 6 months
- Iodine exposition in the last 6 months
- thyroid surgery or radioiodine therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Jena
Jena, Thuringia, 07747
Martin Freesmeyer, Dr.med., +49 3641 9-329805, martin.freesmeyer@med.uni-jena.de
About this study
Official title: 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
- Conditions
- Thyroid Nodule, Thyroid Diseases, Thyroid Goitre
- Being tested
- Assessment of already preacquired I-124 PET/US
- Keywords
- Fusion, Hybrid Imaging, Mapping, Iodine, Ultrasound
- Medical subject headings
- Thyroid Nodule, Thyroid Diseases, Goiter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of already preacquired I-124 PET/USOther
Assessment of preacquired I-124 PET/US by review of anonymous digital case files
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Assessment of already preacquired I-124 PET/US |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start26 Apr 2017
- Primary completionJul 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128255
- Sponsor's protocol ID
- I-124-04/2017
- Acronym
- FUSION iENA
- Status last verified
- Apr 2017
- First submitted
- 20 Apr 2017
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-124 PET/US for Benign Thyroid Diseases - Blinded, Multicentric Assessment of Augmented Thyroid Work-up Versus Regular Thyroid Diagnostics
- ClinicalTrials.gov ID
- NCT03128255
- Acronym / sponsor ID
- FUSION iENA / I-124-04/2017
- Conditions
- Thyroid Nodule, Thyroid Diseases, Thyroid Goitre
- Keywords
- Fusion, Hybrid Imaging, Mapping, Iodine, Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Assessment of already preacquired I-124 PET/USNuclear 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data of patients with unclear findings on regular thyroid work-up who had received additional I-124-PET/US in our institution.
Key inclusion criteria (3 listed)
- patients with thyroidal nodules,
- euthyroidism
- Uptake >0,5% on Tc-99m-pertechnetate- scintigraphy
Key exclusion criteria (3 listed)
- thyroid medications in the last 6 months
- Iodine exposition in the last 6 months
- thyroid surgery or radioiodine therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of already preacquired I-124 PET/USAssessment of preacquired I-124 PET/US by review of anonymous digital case files | Other | Regular Thyroid Work-up and I-124 PET/US |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule and Thyroid Diseases, run by Jena University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Freesmeyer, Dr.med. (+49 3641 9-329805, martin.freesmeyer@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic-sonographic nodule allocation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.