Localization of Parathyroid Adenoma by Fluorocholine Positron Emission Tomography/MRI (PET/MRI): A Prospective Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Assuta Medical Center
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Adenomas size and location
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control Group
primary hyperthyroidism patients that will be refered to the routine exams (PET-CT)
Intervention: PET-CT (Device)
Study group
primary hyperthyroidism patients that will be refered to the routine exams (PET-CT) and in addition will also undergo the PET-MR
Intervention: PET-MR (Device)
Study group
primary hyperthyroidism patients that will be refered to the routine exams (PET-CT) and in addition will also undergo the PET-MR
Intervention: PET-CT (Device)
Outcomes
Primary Outcomes
Adenomas size and location
Time Frame: 24 months
Location of adenomas by a report analyzing the pathological examination (PET-CT/PET-MR output).
Secondary Outcomes
- Parathyroid hormone levels(24 months)
- Disease related medication consumption(24 months)
- Chronic disease duration(24 months)
Investigators
Avi Hefetz
MD
Assuta Medical Center