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NCT Number: NCT07463625

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

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.

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.

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Key information

Conditions

Cushing Disease ACTH-Secreting Pituitary Adenoma ACTH-producing Pituitary Tumour Adenoma Brain Diseases Central Nervous System Diseases Endocrine Gland Neoplasms Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Pituitary ACTH Hypersecretion Pituitary Diseases Pituitary Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Louis Pradel - Service de Médecine Nucléaire

Bron, 69500, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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

Other

No study-specific procedures. The study evaluates existing [18F]FET PET imaging pituitary MRI, and routine biochemical markers collected as part of standard care.

Primary outcomes

  1. [18F]FET PET Performance for Localizing Corticotroph Pituitary Adenomas

    Time frame: 3 months

    Proportion (%) of correct localization of the adenoma by [18F]FET PET, using postoperative histopathological examination of the surgical specimen as the reference standard.

Secondary outcomes

  1. Effect of PET on Tumor Localization Versus MRI

    Time frame: 3 months

    Among cases in which the PET-suggested localization differs from MRI, the proportion (%) in which PET correctly localizes the adenoma (per the primary endpoint definition).

  2. Inter-Reader Agreement of [18F]FET PET Interpretation

    Time frame: 1 month

    Proportion (%) agreement between the two nuclear medicine physicians' PET interpretations (inter-reader agreement).

  3. Correlation Between PET SUV and Hypercortisolism Biomarkers

    Time frame: 3 months

    Correlation between [18F]FET PET and biochemical markers

  4. Determinants of PET Performance (Clinical/Biological/Imaging)

    Time frame: 3 months

    Univariable and multivariable analyses of variables that may influence PET results.

  5. Prognostic Value of PET Findings for Biological Remission

    Time frame: 3 months

    Correlation between PET results and the patient's biological status at follow-up (biological remission-e.g., corticotroph inertia or normalization of urinary free cortisol (UFC)-versus active hypercortisolism).

Study contacts

Contact information is provided by the study sponsor or research team.

Anthime FLAUS, MD

CONTACT

[email protected]

+33 4 72 35 69 99

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Evaluation of [18F]FET PET for the Detection of ACTH-Secreting Corticotroph Pituitary Neuroendocrine Tumors

Acronym: PiTFET

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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