search
Back to results

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

Primary Purpose

Primary Hyperthyroidism

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
PET-MR
PET-CT
Sponsored by
Assuta Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Primary Hyperthyroidism focused on measuring Positron emission tomography-magnetic resonance imaging (PET-MR), Hyperthyroidism, Positron emission tomography-computed tomography (PET-CT)

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Assuta Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Control Group

Study group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
Chronic disease duration
time from chronic diseases indication and duration of symptoms measured in months (from the medical records).
Disease related medication consumption
Disease related medication consumption measured in miligram (mg) for each medication (from medical records).

Full Information

First Posted
July 14, 2016
Last Updated
July 21, 2016
Sponsor
Assuta Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02843542
Brief Title
Localization of Parathyroid Adenoma by Fluorocholine PET/MRI (Positron Emission Tomography -MRI)
Official Title
Localization of Parathyroid Adenoma by Fluorocholine Positron Emission Tomography/MRI (PET/MRI): A Prospective Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assuta Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hyperthyroidism
Keywords
Positron emission tomography-magnetic resonance imaging (PET-MR), Hyperthyroidism, Positron emission tomography-computed tomography (PET-CT)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Other
Arm Description
primary hyperthyroidism patients that will be refered to the routine exams (PET-CT)
Arm Title
Study group
Arm Type
Other
Arm Description
primary hyperthyroidism patients that will be refered to the routine exams (PET-CT) and in addition will also undergo the PET-MR
Intervention Type
Device
Intervention Name(s)
PET-MR
Intervention Description
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
Intervention Name(s)
PET-CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adenomas size and location
Description
Location of adenomas by a report analyzing the pathological examination (PET-CT/PET-MR output).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Parathyroid hormone levels
Description
approval late addition level of parathyroid hormone (PTH) before and during the course of the operation after the conclusion of adenomas (Hormone levels).
Time Frame
24 months
Title
Chronic disease duration
Description
time from chronic diseases indication and duration of symptoms measured in months (from the medical records).
Time Frame
24 months
Title
Disease related medication consumption
Description
Disease related medication consumption measured in miligram (mg) for each medication (from medical records).
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avi Hefetz, MD
Phone
972528661361
Email
avihef1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avi hefetz, MD
Organizational Affiliation
Assuta Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assuta Medical Center
City
Tel-Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avi Hefetz, MD
Phone
972528661361
Email
avihef1@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs