Improvement of imaging techniques in preoperative localization diagnostics in primary hyperparathyroidism

Not Applicable

Conditions: E21.0
Primary hyperparathyroidism

Registration Number: DRKS00017394

Lead Sponsor: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 155

Inclusion Criteria

• Patients with initial diagnosis or recurrence of chemically proven primary hyperparathyroidism and planned parathyroidectomy
• Age = 18 years
• signed declaration of consent

Exclusion Criteria

• advanced renal failure (GFR <30 ml / min)
• presence of a non-MRI pacemaker or scheduled implant
• Metal splinters or vessel clips made of ferromagnetic material in unfavorable position (eg in the eye, brain)
• temporary cava filter
• non-MRI-enabled cochlear implants
• insulin pumps
• claustrophobia
• any other condition in which the trial is impossible or risky to the patient (for example psychiatric disorders)
• legally incompetent patients
• pregnancy or inadequate contraception in childbearing age (oral contraceptives, IUD, barrier methods are sufficient)
• breastfeeding

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
As a primary goal sensitivity and specificity of 4D-MRI in comparison to ultrasound and sestamibi is assessed. Therefore, statistical analysis will be performed using McNemar’s test and 95% confidence intervals will be constructed.

Secondary Outcome Measures

Name	Time	Method
As a secondary goal further explorative analysis concerning impacts on operation technique and duration, postoperative complications, intraoperative parathormone testing and length of hospital stay are planned.