Localization of Parathyroid Adenoma by Fluorocholine PET/MRI (Positron Emission Tomography -MRI)

Study Overview
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Brief Summary
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A comparative prospective study to evaluate different imaging modalities (pet-ct and pet-mr) prior to surgery in parathyroid tumor patients.

Detailed Description
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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.

Official Title
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Localization of Parathyroid Adenoma by Fluorocholine Positron Emission Tomography/MRI (PET/MRI): A Prospective Pilot Study

Conditions
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Primary Hyperthyroidism

Intervention / Treatment
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* Device: PET-MR
* Device: PET-CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Group<br>primary hyperthyroidism patients that will be refered to the routine exams (PET-CT) | Device: PET-CT<br>* 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.<br>|
| Other: Study group<br>primary hyperthyroidism patients that will be refered to the routine exams (PET-CT) and in addition will also undergo the PET-MR | Device: PET-MR<br>* 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.<br>Device: PET-CT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenomas size and location | Location of adenomas by a report analyzing the pathological examination (PET-CT/PET-MR output). | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 24 months | 
| Chronic disease duration | time from chronic diseases indication and duration of symptoms measured in months (from the medical records). | 24 months | 
| Disease related medication consumption | Disease related medication consumption measured in miligram (mg) for each medication (from medical records). | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positron emission tomography-magnetic resonance imaging (PET-MR), Hyperthyroidism, Positron emission tomography-computed tomography (PET-CT)