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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

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

Condition or disease Intervention/treatment Phase
Primary Hyperthyroidism Device: PET-MR Device: PET-CT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Localization of Parathyroid Adenoma by Fluorocholine Positron Emission Tomography/MRI (PET/MRI): A Prospective Pilot Study
Study Start Date : August 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperthyroidism

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




Primary Outcome Measures :
  1. Adenomas size and location [ Time Frame: 24 months ]
    Location of adenomas by a report analyzing the pathological examination (PET-CT/PET-MR output).


Secondary Outcome Measures :
  1. 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).

  2. Chronic disease duration [ Time Frame: 24 months ]
    time from chronic diseases indication and duration of symptoms measured in months (from the medical records).

  3. Disease related medication consumption [ Time Frame: 24 months ]
    Disease related medication consumption measured in miligram (mg) for each medication (from medical records).



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843542


Contacts
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Contact: Avi Hefetz, MD 972528661361 avihef1@gmail.com

Locations
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Israel
Assuta Medical Center Not yet recruiting
Tel-Aviv, Israel
Contact: Avi Hefetz, MD    972528661361    avihef1@gmail.com   
Sponsors and Collaborators
Assuta Medical Center
Investigators
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Principal Investigator: Avi hefetz, MD Assuta Medical Center

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Responsible Party: Avi Hefetz, MD, Assuta Medical Center
ClinicalTrials.gov Identifier: NCT02843542     History of Changes
Other Study ID Numbers: 0012-16-ASMC
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Avi Hefetz, Assuta Medical Center:
Positron emission tomography-magnetic resonance imaging (PET-MR)
Hyperthyroidism
Positron emission tomography-computed tomography (PET-CT)
Additional relevant MeSH terms:
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Adenoma
Parathyroid Neoplasms
Hyperthyroidism
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Parathyroid Diseases
Parathyroid Hormone
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs