Localization of Parathyroid Adenoma by Fluorocholine PET/MRI (Positron Emission Tomography -MRI)
1 other identifier
interventional
50
1 country
1
Brief Summary
A comparative prospective study to evaluate different imaging modalities (pet-ct and pet-mr) prior to surgery in parathyroid tumor patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJuly 26, 2016
July 1, 2016
2 years
July 14, 2016
July 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adenomas size and location
Location of adenomas by a report analyzing the pathological examination (PET-CT/PET-MR output).
24 months
Secondary Outcomes (3)
Parathyroid hormone levels
24 months
Chronic disease duration
24 months
Disease related medication consumption
24 months
Study Arms (2)
Control Group
OTHERprimary hyperthyroidism patients that will be refered to the routine exams (PET-CT)
Study group
OTHERprimary hyperthyroidism patients that will be refered to the routine exams (PET-CT) and in addition will also undergo the PET-MR
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assuta Medical Center
Tel Aviv, Israel, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Avi hefetz, MD
Assuta Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 14, 2016
First Posted
July 26, 2016
Study Start
August 1, 2016
Primary Completion
August 1, 2018
Study Completion
December 1, 2018
Last Updated
July 26, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share