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

Not Applicable

• Conditions: Primary Hyperthyroidism
• Interventions: Device: PET-MR; Device: PET-CT

• Registration Number: NCT02843542
• Lead Sponsor: Assuta Medical Center

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 Timeline

• Status Verified: 2016-07
• Study First Submitted: 2016-07-14
• Study First Submitted QC: 2016-07-21
• Last Update Submitted: 2016-07-21
• Study First Posted: 2016-07-26
• Last Update Posted: 2016-07-26
• Study Start: 2016-08
• Primary Completion: 2018-08
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	PET-MR	primary hyperthyroidism patients that will be refered to the routine exams (PET-CT) and in addition will also undergo the PET-MR
Control Group	PET-CT	primary hyperthyroidism patients that will be refered to the routine exams (PET-CT)
Study group	PET-CT	primary hyperthyroidism patients that will be refered to the routine exams (PET-CT) and in addition will also undergo the PET-MR

Primary Outcome Measures

Name	Time	Method
Adenomas size and location	24 months	Location of adenomas by a report analyzing the pathological examination (PET-CT/PET-MR output).

Secondary Outcome Measures

Name	Time	Method
Parathyroid hormone levels	24 months	approval late addition level of parathyroid hormone (PTH) before and during the course of the operation after the conclusion of adenomas (Hormone levels).
Disease related medication consumption	24 months	Disease related medication consumption measured in miligram (mg) for each medication (from medical records).
Chronic disease duration	24 months	time from chronic diseases indication and duration of symptoms measured in months (from the medical records).

Trial Locations

Locations (1)

Assuta Medical Center; 🇮🇱 Tel-Aviv, Israel