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

NCT ID: NCT02843542

Last Updated: 2016-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-12-31

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.

Conditions

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Primary Hyperthyroidism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Control Group

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

Group Type OTHER

PET-CT

Intervention Type DEVICE

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.

Study group

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

Group Type OTHER

PET-MR

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assuta Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Avi Hefetz

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Avi hefetz, MD

Role: PRINCIPAL_INVESTIGATOR

Assuta Medical Center

Locations

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Assuta Medical Center

Tel Aviv, Israel, Israel

Site Status

Countries

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Israel

Central Contacts

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Avi Hefetz, MD

Role: CONTACT

972528661361

Facility Contacts

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Avi Hefetz, MD

Role: primary

972528661361

Other Identifiers

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0012-16-ASMC

Identifier Type: -

Identifier Source: org_study_id

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