Cushing DiseasePiTFETNCT07463625
Evaluation of Positron Emission Tomography (PET) With [18F]FET for the Detection of ACTH-Secreting Corticotroph Pituitary Neuroendocrine Tumors.
An observational study of Cushing Disease and ACTH-producing Pituitary Tumour, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing Disease, ACTH-producing Pituitary Tumour
- What is being tested?
- Data-only evaluation of [18F]FET PET, pituitary MRI, and biomarkers
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2023to 23 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults treated at a tertiary academic hospital with biochemically confirmed Cushing's disease, evaluated by pituitary MRI and [18F]FET PET as part of diagnostic work-up, and discussed for surgery.
Who may be able to join
- 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 join
- Minor (age <18 years).
- Macroadenoma of the pituitary.
- ACTH-dependent hypercortisolism secondary to ectopic secretion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Louis Pradel - Service de Médecine Nucléaire
Bron, 69500
About this study
Official title: Evaluation of [18F]FET PET 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.
Read more
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:
- assessing cases in which PET modifies localization relative to MRI and is correct by gold standard;
- inter-reader agreement between two nuclear medicine physicians;
- correlations between PET signal and biochemical markers of hypercortisolism
- uni- and multivariable analyses of clinical and imaging parameters influencing PET results;
- association between PET findings and subsequent biological remission.
- Conditions
- Cushing Disease, ACTH-producing Pituitary Tumour
- Being tested
- Data-only evaluation of [18F]FET PET, pituitary MRI, and biomarkers
- Keywords
- PET, Cushing disease, [18F]FET, PitNET, Corticotroph adenoma, ACTH, Pituitary, MRI, Amino-acid
- Medical subject headings
- Pituitary ACTH Hypersecretion, ACTH-Secreting Pituitary Adenoma, Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data-only evaluation of [18F]FET PET, pituitary MRI, and biomarkersOther
No study-specific procedures. The study evaluates existing [18F]FET PET imaging pituitary MRI, and routine biochemical markers collected as part of standard care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data-only evaluation of [18F]FET PET, pituitary MRI, and biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
[18F]FET PET Performance for Localizing Corticotroph Pituitary Adenomas
Proportion (%) of correct localization of the adenoma by [18F]FET PET, using postoperative histopathological examination of the surgical specimen as the reference standard.
Measured: 3 months
Secondary outcomes (5)
Effect of PET on Tumor Localization Versus MRI
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).
Measured: 3 months
Inter-Reader Agreement of [18F]FET PET Interpretation
Proportion (%) agreement between the two nuclear medicine physicians' PET interpretations (inter-reader agreement).
Measured: 1 month
Correlation Between PET SUV and Hypercortisolism Biomarkers
Correlation between [18F]FET PET and biochemical markers
Measured: 3 months
Determinants of PET Performance (Clinical/Biological/Imaging)
Univariable and multivariable analyses of variables that may influence PET results.
Measured: 3 months
Prognostic Value of PET Findings for Biological Remission
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start23 Nov 2023
- Primary completion23 Nov 2027 (estimated)
- Study completion23 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463625
- Sponsor's protocol ID
- 25-5027
- Acronym
- PiTFET
- Status last verified
- Mar 2026
- First submitted
- 2 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of [18F]FET PET for the Detection of ACTH-Secreting Corticotroph Pituitary Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT07463625
- Acronym / sponsor ID
- PiTFET / 25-5027
- Conditions
- Cushing Disease, ACTH-producing Pituitary Tumour
- Keywords
- PET, Cushing disease, [18F]FET, PitNET, Corticotroph adenoma, ACTH, Pituitary, MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 23 Nov 2027 (estimated)
- Study completion
- 23 Nov 2028 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- assessing cases in which PET modifies localization relative to MRI and is correct by gold standard;
- inter-reader agreement between two nuclear medicine physicians;
- correlations between PET signal and biochemical markers of hypercortisolism
- uni- and multivariable analyses of clinical and imaging parameters influencing PET results;
- association between PET findings and subsequent biological remission.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with Cushing's disease evaluated for pituitary surgery | – | Other: Data-only evaluation of [18F]FET PET, pituitary MRI, and biomarkersAdults (≥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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults treated at a tertiary academic hospital with biochemically confirmed Cushing's disease, evaluated by pituitary MRI and [18F]FET PET as part of diagnostic work-up, and discussed for surgery.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Minor (age <18 years).
- Macroadenoma of the pituitary.
- ACTH-dependent hypercortisolism secondary to ectopic secretion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data-only evaluation of [18F]FET PET, pituitary MRI, and biomarkersNo study-specific procedures. The study evaluates existing [18F]FET PET imaging pituitary MRI, and routine biochemical markers collected as part of standard care. | Other | Adults with Cushing's disease evaluated for pituitary surgery |
Primary outcome
[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.
5 secondary outcomes
Effect of PET on Tumor Localization Versus MRI
Time frame: 3 months
Inter-Reader Agreement of [18F]FET PET Interpretation
Time frame: 1 month
Correlation Between PET SUV and Hypercortisolism Biomarkers
Time frame: 3 months
Determinants of PET Performance (Clinical/Biological/Imaging)
Time frame: 3 months
Prognostic Value of PET Findings for Biological Remission
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cushing Disease and ACTH-producing Pituitary Tumour, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthime FLAUS, MD (+33 4 72 35 69 99, anthime.flaus@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[18F]FET PET Performance for Localizing Corticotroph Pituitary Adenomas (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.