ACTH-dependent hypercortisolism
Conditions
Brief summary
The primary endpoint of this prospective evaluation is the difference in the proportion of patients with ACTH-dependent hypercortisolism in whom CD is correctly distinguished from ectopic CS using [18F]FET PET-MRI versus IPSS. [18F]FET PET-MRI will be compared for non-inferiority to the current standard IPSS.
Detailed description
Secondary endpoints include the sensitivity, specificity, positive and negative predictive value of the two techniques for the exact localization of ACTH-secreting PitNETs, based on post-operative neurosurgery and pathology reports as well as biochemical remission as reference standards. The area under the curve (AUC) for both techniques will be calculated from the receiver operating curve (ROC).
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this prospective evaluation is the difference in the proportion of patients with ACTH-dependent hypercortisolism in whom CD is correctly distinguished from ectopic CS using [18F]FET PET-MRI versus IPSS. [18F]FET PET-MRI will be compared for non-inferiority to the current standard IPSS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the sensitivity, specificity, positive and negative predictive value of the two techniques for the exact localization of ACTH-secreting PitNETs, based on post-operative neurosurgery and pathology reports as well as biochemical remission as reference standards. The area under the curve (AUC) for both techniques will be calculated from the receiver operating curve (ROC). | — |
Countries
Netherlands