Primary HyperthyroidismNCT02843542
Localization of Parathyroid Adenoma by Fluorocholine PET/MRI (Positron Emission Tomography -MRI)
A study testing PET-MR and PET-CT in people with Primary Hyperthyroidism, run by Assuta Medical Center at 1 site in Israel.
Trial summary
A comparative prospective study to evaluate different imaging modalities (pet-ct and pet-mr) prior to surgery in parathyroid tumor patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Primary Hyperthyroidism
- What is being tested?
- PET-MR and PET-CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2016to Dec 2018
- Phase
- Interventional
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who meet the criteria accepted in the World Health Organization (WHO) analysis:
- Symptomatic patients (constipation, depression, peptic ulcer, pathologic fractures, chronic fatigue, pain from a urinary tract stones etc..)
- or at least one of the following criteria:
- Blood calcium levels above 1 more than normal
- Creatinine clearance decreased in 30% from age expected
- Urine Creatinine above 400 mg in 24 hours
Who cannot join
- Patients with hyperthyroidism secondary and tertiary (secondary to kidney disease)
- Patients who are not eligible to sign an informed consent
- Pregnant women
- Patients with sensitivity (allergy) technetium or 18FCH
Trial locations and contacts
1 site in 1 country.
Israel1 site
Assuta Medical Center
Tel Aviv, Israel
Avi Hefetz, MD, 972528661361, avihef1@gmail.com
About this study
Official title: Localization of Parathyroid Adenoma by Fluorocholine Positron Emission Tomography/MRI (PET/MRI): A Prospective Pilot Study
A comparative prospective study to evaluate different imaging modalities (pet-ct and pet-mr) prior to surgery in parathyroid tumor patients.
Read the detailed description
Patients with Hyperthyroidism and surgery indication will be recruited and directed to imagine exams. in addition to the conservative 99mTc-MIBI (methoxyisobutylisonitrile) and US, patients will also undergo 18FCH (¹⁸F-choline) PET/MRI for detecting adenomas and their location. imaging experts will decode the imaging exams. sensitivity and specificity of the exams will be examined.
- Conditions
- Primary Hyperthyroidism
- Being tested
- PET-MR, PET-CT
- Keywords
- Positron emission tomography-magnetic resonance imaging (PET-MR), Hyperthyroidism, Positron emission tomography-computed tomography (PET-CT)
- Medical subject headings
- Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MRDevice
Patients with Hyperthyroidism and surgery indication will be recruited and directed to imagine exams. In addition to the conservative 99mTc-MIBI and US, patients will also undergo 18FCH PET/MRI for detecting adenomas and their location.
PET-CTDevice
Patients with Hyperthyroidism and surgery indication will be recruited and directed to imagine exams. In addition to the conservative 99mTc-MIBI and US, patients will also undergo PET-CT for detecting adenomas and their location.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | primary hyperthyroidism patients that will be refered to the routine exams (PET-CT) Receives: Device: PET-CT |
| Study group | Other | primary hyperthyroidism patients that will be refered to the routine exams (PET-CT) and in addition will also undergo the PET-MR Receives: Device: PET-MR; Device: PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenomas size and location
Location of adenomas by a report analyzing the pathological examination (PET-CT/PET-MR output).
Measured: 24 months
Secondary outcomes (3)
Parathyroid hormone levels
approval late addition level of parathyroid hormone (PTH) before and during the course of the operation after the conclusion of adenomas (Hormone levels).
Measured: 24 months
Chronic disease duration
time from chronic diseases indication and duration of symptoms measured in months (from the medical records).
Measured: 24 months
Disease related medication consumption
Disease related medication consumption measured in miligram (mg) for each medication (from medical records).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperthyroidismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avi Hefetz, Assuta Medical Center
- Investigators
- Avi hefetz, MD, Principal investigator, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843542
- Sponsor's protocol ID
- 0012-16-ASMC
- Status last verified
- Jul 2016
- First submitted
- 14 Jul 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localization of Parathyroid Adenoma by Fluorocholine Positron Emission Tomography/MRI (PET/MRI): A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT02843542
- Acronym / sponsor ID
- 0012-16-ASMC
- Conditions
- Primary Hyperthyroidism
- Keywords
- Positron emission tomography-magnetic resonance imaging (PET-MR), Hyperthyroidism, Positron emission tomography-computed tomography (PET-CT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 Jul 2016 (estimated)
- 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.
A comparative prospective study to evaluate different imaging modalities (pet-ct and pet-mr) prior to surgery in parathyroid tumor patients.
Detailed description
Patients with Hyperthyroidism and surgery indication will be recruited and directed to imagine exams. in addition to the conservative 99mTc-MIBI (methoxyisobutylisonitrile) and US, patients will also undergo 18FCH (¹⁸F-choline) PET/MRI for detecting adenomas and their location. imaging experts will decode the imaging exams. sensitivity and specificity of the exams will be examined.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Device: PET-CTprimary hyperthyroidism patients that will be refered to the routine exams (PET-CT) |
| Study group | Other | Device: PET-MR, Device: PET-CTprimary hyperthyroidism patients that will be refered to the routine exams (PET-CT) and in addition will also undergo the PET-MR |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Symptomatic patients (constipation, depression, peptic ulcer, pathologic fractures, chronic fatigue, pain from a urinary tract stones etc..)
- Blood calcium levels above 1 more than normal
- Creatinine clearance decreased in 30% from age expected
- Urine Creatinine above 400 mg in 24 hours
Key exclusion criteria (4 listed)
- Patients with hyperthyroidism secondary and tertiary (secondary to kidney disease)
- Patients who are not eligible to sign an informed consent
- Pregnant women
- Patients with sensitivity (allergy) technetium or 18FCH
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 |
|---|---|---|
| PET-MRPatients with Hyperthyroidism and surgery indication will be recruited and directed to imagine exams. In addition to the conservative 99mTc-MIBI and US, patients will also undergo 18FCH PET/MRI for detecting adenomas and their location. | Device | Study group |
| PET-CTPatients with Hyperthyroidism and surgery indication will be recruited and directed to imagine exams. In addition to the conservative 99mTc-MIBI and US, patients will also undergo PET-CT for detecting adenomas and their location. | Device | Control Group, Study group |
Primary outcome
Adenomas size and location
Time frame: 24 months
Location of adenomas by a report analyzing the pathological examination (PET-CT/PET-MR output).
3 secondary outcomes
Parathyroid hormone levels
Time frame: 24 months
Chronic disease duration
Time frame: 24 months
Disease related medication consumption
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Individual participant dataSharing planned: No
Related trials for Primary Hyperthyroidism
RecruitingPhase 2
An Open-label, Rollover Trial to Evaluate the Efficacy and Safety of AMG 732 in Participants With Thyroid Eye Disease
Thyroid Eye Disease
RecruitingObservational study
Efficacy of Thermal Ablation Combined With Antithyroid Drugs in the Treatment of Primary Hyperthyroidism
Complication Rate, Efficacy and Safety
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.
Avi hefetz, MD principal investigator
Assuta Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-MR and PET-CT in people with Primary Hyperthyroidism, run by Assuta Medical Center at 1 site in Israel.
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 6 inclusion and 4 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 26 Jul 2016. 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 Israel. 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 Avi Hefetz, MD (972528661361, avihef1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenomas size and location (time frame: 24 months). 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 26 Jul 2016.