Use of [18F]FET PET-MRI to Improve Detection of Pituitary Adenomas in Cushing's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [18F]FET PET-MRI.
- Who it may be relevant to
- Registry conditions: Cushing Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of [18F]FET PET-MRI to Improve Detection of Pituitary Adenomas in Cushing's Disease - a Prospective Diagnostic Study
Overview
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.
Interventions
- Diagnostic test [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 participan
Primary outcome measures
- Comparison of the proportion of correct distinctions between CD and ectopic CS in patients with ACTH-dependent hypercortisolism using [18F]FET PET-MRI versus IPSS [Time frame: Patients will receive standard surgical or radiotherapeutic treatment. The study will collect follow-up data 3-6 months post-treatment without influencing clinical management or requiring study-specific visits.]
Secondary outcome measures (6)
- Copeptin values during IPSS [Time frame: During the IPSS]
- ACTH values during IPSS [Time frame: During the IPSS]
- Comparison of the diagnostic accuracy between [18F]FET PET-MRI and IPSS for differentiating between CD and ectopic CS in patients with ACTH-dependent hy-percortisolism [Time frame: Follow-up data 3-6 months post-treatment]
- Exact localization of small functional PitNETs in patients with CD using the [18F]FET PET-MRI [Time frame: perioperative]
- Exact localization of small functional PitNETs in patients with CD using the inferior petrosal sinus sampling (IPSS) [Time frame: perioperative]
- Exact localization of small functional PitNETs in patients with CD using the structural MRI [Time frame: perioperative]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Netherlands · 1 center
- Erasmus University Medical Centre — Rotterdam
Switzerland · 1 center
- University Hospital Basel — Basel
Identifiers
NCT: NCT07108244 · FIND study