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

Assuta Medical Center

Status: Unknown

Conditions: Primary Hyperthyroidism

Treatments: Device: PET-MR; Device: PET-CT

Study type: Interventional

Funder types: Other

Identifiers

NCT02843542

0012-16-ASMC

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Control Group

Other group

Description:

primary hyperthyroidism patients that will be refered to the routine exams (PET-CT)

Treatment:

Device: PET-CT

Study group

Other group

Description:

primary hyperthyroidism patients that will be refered to the routine exams (PET-CT) and in addition will also undergo the PET-MR

Treatment:

Device: PET-CT

Device: PET-MR