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Use of [18F]FET PET-MRI to Improve Detection of Pituitary Adenomas in Cushing's Disease

NCT ID: NCT07108244

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-22

Study Completion Date

2029-07-30

Brief Summary

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In ACTH-dependent hypercortisolism it is important to distinguish between Cushing's disease (CD), with ACTH production by a pituitary neuroendocrine tumour (PitNET) and Cushing's syndrome (CS), with ectopic ACTH production. Bilateral inferior petrosal sinus sampling (IPSS) is the gold standard for this distinction, with a diagnostic accuracy of 98%. However, IPSS is an invasive procedure and an indi-rect diagnostic method, rarely providing reliable data on the exact location of the PitNET. This has a major impact on the therapeutic approach, short and long-term remission rates, and other outcomes. Hybrid Positron-emission tomography-Magnetic Resonance Imaging (PET-MRI) using O-(2-\[18F\]-fluo-roethyl)-L-tyrosine (\[18F\]FET) is promising in this respect. Recent data published by our research group demonstrate a a sensitivity of 100% a high accuracy in in the precise localization of ACTH-secreting PitNETs. We hypothesize that \[18F\]FET PET-MRI could become the new non-invasive diagnostic stand-ard, but data regarding a direct comparison between the diagnostic impact of \[18F\]FET PET-MRI versus IPSS in the differentiation between CD and ectopic CS are lacking. In addition, there are currently no other reliable biomarkers to distinguish the two disorders. The investigators hypothesize that the ACTH-dependent biomarker copeptin could be a valuable addition in this regard. The aim of this prospective diagnostic study is to compare the diagnostic accuracy of \[18F\]FET-PET-MRI and IPSS in differentiating CD from ectopic CS in patients with ACTH-dependent hypercortisolism.

Detailed Description

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Conditions

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Cushing Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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[18F]FET-PET-MRI vs IPSS for diagnosing CD vs ectopic CS in ACTH-dependent cases

Participants will undergo both \[18F\]FET-PET-MRI and inferior petrosal sinus sampling (IPSS) to evaluate their diagnostic performance in differentiating Cushing's disease from ectopic ACTH secretion. Results of both procedures will be made available to the treating medical team and participants as they become available.

Group Type OTHER

[18F]FET PET-MRI

Intervention Type DIAGNOSTIC_TEST

All participants will undergo both \[18F\]fluoroethyltyrosine positron emission tomography-magnetic resonance imaging (\[18F\]FET-PET-MRI) and inferior petrosal sinus sampling (IPSS) as part of the diagnostic work-up for ACTH-dependent hypercortisolism. The purpose is to compare the diagnostic accuracy of these two modalities in distinguishing Cushing's disease from ectopic ACTH secretion. The results from both diagnostic tests will be communicated to the treating medical team and the participant to guide further clinical management.

Interventions

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[18F]FET PET-MRI

All participants will undergo both \[18F\]fluoroethyltyrosine positron emission tomography-magnetic resonance imaging (\[18F\]FET-PET-MRI) and inferior petrosal sinus sampling (IPSS) as part of the diagnostic work-up for ACTH-dependent hypercortisolism. The purpose is to compare the diagnostic accuracy of these two modalities in distinguishing Cushing's disease from ectopic ACTH secretion. The results from both diagnostic tests will be communicated to the treating medical team and the participant to guide further clinical management.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* 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
* Elevated late night salivary cortisol (min. 2/3 measurements)
* Elevated 24-hours urinary free cortisol (min. 2 measurements)
* Pituitary microadenoma (\< 10mm) OR negative / inconclusive findings on standard MRI of the pituitary sella-region.
* Indication for further evaluation with IPSS

Exclusion Criteria

* Non-ACTH dependent hypercortisolism
* Pituitary macroadenoma (≥ 10mm)
* Suspicion of Pseudo-Cushing's disease (e.g. due to alcohol use disorder, PCO's, obesity, de-pression) according to standard work up / guidelines
* use of glucocorticosteroids
* Impaired renal function, defined as eGFR (MDRD) \<30ml/min/1,73 m2. An exception can be made in consultation with the treating physician.
* Impaired Liver function
* Pregnancy/breastfeeding. For the latter, temporary discontinuation may be considered.
* Known allergic reaction to therapeutic radiopharmaceuticals.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Erasmus University Medical Centre

Rotterdam, South Holland, Netherlands

Site Status

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Netherlands Switzerland

Other Identifiers

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FIND study

Identifier Type: -

Identifier Source: org_study_id