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Use of [18F]FET PET-MRI to improve detection of pituitary adenomas in Cushing’s disease

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518908-46-00
Enrollment
30
Registered
2025-05-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACTH-dependent hypercortisolism

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

DRUGFET

Sponsors

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026