E21.0
Conditions
Interventions
Group 1: 155 patients with primary hyperparathyroidism and indication for surgical therapy are included in an open, prospective study. Besides routine guideline recommended diagnostic methods, like ul
Sponsors
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactAntonia Mondorf
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
Outcome results
None listed