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Evaluation of Positron Emission Tomography (PET) With [18F]FET for the Detection of ACTH-Secreting Corticotroph Pituitary Neuroendocrine Tumors.

Key facts

Who runs it
Hospices Civils de Lyon
Where
France1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
20 people, planned
Started
23 Nov 2023
Expected to end
23 Nov 2028
Type of study
Observational
Treatments tested
  • Data-only evaluation of [18F]FET PET, pituitary MRI, and biomarkers
Record updated
11 March 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

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Who can take part

  • Adults (≥18 years)
  • Biochemical diagnosis of Cushing's disease as part of initial management
  • Pituitary MRI performed; if visible, microadenoma <10 mm in diameter
  • Indication for discussion in multidisciplinary tumor board for surgical management

Who cannot take part

  • Minor (age <18 years)
  • Macroadenoma of the pituitary
  • ACTH-dependent hypercortisolism secondary to ectopic secretion

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Cushing's disease results from adrenocorticotropic hormone (ACTH) secretion by corticotroph pituitary neuroendocrine tumors (PitNETs). Magnetic resonance imaging (MRI) is the reference modality for etiological diagnosis but may to visualize small corticotroph microadenomas in up to 30% of the cases, and false positives may occur.

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The study hypothesis is that positron emission tomography (PET) using [18F]fluoroethyl-L-tyrosine ([18F]FET) improves localization of ACTH-secreting corticotroph microadenomas compared with MRI and could inform surgical planning and reduce reliance on invasive inferior petrosal sinus sampling.

This observational cohort (retrospective and prospective data) will assess the diagnostic performance of [18F]FET PET for tumor localization using postoperative histopathology as the gold standard.

Secondary aims include:

1. assessing cases in which PET modifies localization relative to MRI and is correct by gold standard; 2. inter-reader agreement between two nuclear medicine physicians; 3. correlations between PET signal and biochemical markers of hypercortisolism 4. uni- and multivariable analyses of clinical and imaging parameters influencing PET results; 5. association between PET findings and subsequent biological remission.

The group in the trial

  • Adults with Cushing's disease evaluated for pituitary surgery

    Adults (≥18 years) with biochemically confirmed Cushing's disease with negative or doubtlful or microadenoma on pituitary MRI and are discussed for surgical management; who benefited from a\[18F\]FET PET in their clinical work-up.

    Treatment: Data-only evaluation of [18F]FET PET, pituitary MRI, and biomarkers

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

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of [18F]FET PET for the Detection of ACTH-Secreting Corticotroph Pituitary Neuroendocrine Tumors
Record updated
11 March 2026