FLUOROETHYLTYROSINE F-18 for ACTH-dependent hypercortisolism | Cushing's disease

Inclusion criteria

• {"criterion_text":"- In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Age ≥18 years\n- 2. Biochemically confirmed ACTH-dependent hypercortisolism, defined as: Non-suppressed ACTH levels plus minimal 2 of the following: Overnight 1mg dexamethasone suppression test > 50 nmol/L; and/or Elevated late night salivary cortisol (min. 2/3 measurements); and/or Elevated 24-hours urinary free cortisol (min. 2 measurements)\n- 3. Pituitary microadenoma (< 10mm) OR negative / inconclusive findings on standard MRI of the pituitary sella-region.\n- 4. Indication for further evaluation with IPSS."}

Exclusion criteria

• {"criterion_text":"- A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Non-ACTH dependent hypercortisolism;\n- 2. Pituitary macroadenoma (≥ 10mm);\n- 3. Suspicion of Pseudo-Cushing’s disease (e.g. due to alcohol use disorder, PCO’s, obesity, depression) according to standard work up / guidelines;\n- 4. Use of glucocorticosteroids;\n- 5. Impaired renal function, defined as eGFR (MDRD) <30ml/min/1,73 m2. An exception can be made in consultation with the treating physician;\n- 6. Impaired Liver function;\n- 7. Pregnancy/breastfeeding. For the latter, temporary discontinuation may be considered;\n- 8. Known allergic reaction to therapeutic radiopharmaceuticals;\n- 9. Inability to lie still in supine position for the duration of the PET-MRI scan;\n- 10. •\tOther conditions that make it impossible to perform a PET-MRI scan, such as neurological disease, severe immobility, or unsuppressable claustrophobia."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Difference in proportion of patients with ACTH-dependent hypercortisolism in whom Cushing's disease is correctly differentiated from ectopic Cushing's syndrome using [18F]FET PET-MRI versus IPSS; non-inferiority comparison to IPSS."}

Secondary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Diagnostic accuracy metrics (sensitivity, specificity, positive and negative predictive value) for [18F]FET-PET-MRI and IPSS for localization of ACTH-secreting PitNETs, using post-operative neurosurgery/pathology reports and biochemical remission as reference standards; AUC calculated from ROC."}

Netherlands

Earliest CTIS Part Ii Submission Date

14-04-2025

Latest Decision Or Authorization Date

15-05-2025

Processing Time Days

31

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands