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

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ClinicalTrials.gov Identifier: NCT02843542
Recruitment Status : Unknown
Verified July 2016 by Avi Hefetz, Assuta Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Avi Hefetz, Assuta Medical Center

Tracking Information
First Submitted Date  ICMJE July 14, 2016
First Posted Date  ICMJE July 26, 2016
Last Update Posted Date July 26, 2016
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2016)
Adenomas size and location [ Time Frame: 24 months ]
Location of adenomas by a report analyzing the pathological examination (PET-CT/PET-MR output).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2016)
  • Parathyroid hormone levels [ Time Frame: 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).
  • Chronic disease duration [ Time Frame: 24 months ]
    time from chronic diseases indication and duration of symptoms measured in months (from the medical records).
  • Disease related medication consumption [ Time Frame: 24 months ]
    Disease related medication consumption measured in miligram (mg) for each medication (from medical records).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Localization of Parathyroid Adenoma by Fluorocholine PET/MRI (Positron Emission Tomography -MRI)
Official Title  ICMJE Localization of Parathyroid Adenoma by Fluorocholine Positron Emission Tomography/MRI (PET/MRI): A Prospective Pilot Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Primary Hyperthyroidism
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Control Group
    primary hyperthyroidism patients that will be refered to the routine exams (PET-CT)
    Intervention: Device: PET-CT
  • Study group
    primary hyperthyroidism patients that will be refered to the routine exams (PET-CT) and in addition will also undergo the PET-MR
    Interventions:
    • Device: PET-MR
    • Device: PET-CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 21, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02843542
Other Study ID Numbers  ICMJE 0012-16-ASMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Avi Hefetz, Assuta Medical Center
Study Sponsor  ICMJE Assuta Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Avi hefetz, MD Assuta Medical Center
PRS Account Assuta Medical Center
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP