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

Primary Hyperthyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02843542
• Other study ID #: 0012-16-ASMC
• Status: Not yet recruiting
• Phase: N/A
• First received: July 14, 2016
• Last updated: July 21, 2016
• Start date: August 2016
• Est. completion date: December 2018

Study information

• Verified date: July 2016
• Source: Assuta Medical Center
• Contact: Avi Hefetz, MD
• Phone: 972528661361
• Email: avihef1[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenoma
• Hyperthyroidism
• Parathyroid Neoplasms
• Primary Hyperthyroidism

Intervention

Device:
• PET-MR
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-CT
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.

Locations

Country	Name	City	State
Israel	Assuta Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenomas size and location	Location of adenomas by a report analyzing the pathological examination (PET-CT/PET-MR output).	24 months	No
Secondary	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	No
Secondary	Chronic disease duration	time from chronic diseases indication and duration of symptoms measured in months (from the medical records).	24 months	No
Secondary	Disease related medication consumption	Disease related medication consumption measured in miligram (mg) for each medication (from medical records).	24 months	No