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Enrolling by invitationNo phase

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

Key facts

Who runs it
University Hospital, Basel, Switzerland
Where
Basel, SwitzerlandSee the siteAlso in 1 other country, 1 site
Trial code
Status
Enrolling by invitation
People taking part
43 people, planned
Started
4 Jun 2026
Expected to end
30 Jul 2029
Type of study
Interventional
Treatments tested
  • [18F]FET PET-MRI
Record updated
6 July 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in Switzerland

Also in 1 other country, 1 site

  • University Hospital BaselBasel, SwitzerlandNo longer taking part

About the trial

What the trial wants to find out

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.

The group in the trial

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

    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.

    Treatment: [18F]FET PET-MRI

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Use of [18F]FET PET-MRI to Improve Detection of Pituitary Adenomas in Cushing's Disease - a Prospective Diagnostic Study
Record updated
6 July 2026