Cushing DiseaseFINDNCT07108244
Use of [18F]FET PET-MRI to Improve Detection of Pituitary Adenomas in Cushing's Disease
A study testing [18F]FET PET-MRI in people with Cushing Disease, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing Disease
- What is being tested?
- [18F]FET PET-MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 Jun 2026to 30 Jul 2029
- Phase
- Interventional
- 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
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Netherlands1 site
Erasmus University Medical Centre
Rotterdam, South Holland, 3015
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Use of [18F]FET PET-MRI to Improve Detection of Pituitary Adenomas in Cushing's Disease - a Prospective Diagnostic Study
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.
- Conditions
- Cushing Disease
- Being tested
- [18F]FET PET-MRI
- Medical subject headings
- Pituitary ACTH Hypersecretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FET PET-MRIDiagnostic test
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 participant to guide further clinical management.
| Study group | Role | What they receive |
|---|---|---|
| [18F]FET-PET-MRI vs IPSS for diagnosing CD vs ectopic CS in ACTH-dependent cases | Other | 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. Receives: Diagnostic Test: [18F]FET PET-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The difference in the proportion of correct distinction between CD and ectopic CS in patients with ACTH-dependent hypercortisolism using [18F]FET PET-MRI versus IPSS
Measured: 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 outcomes (6)
Copeptin values during IPSS
Best fit of diagnostic copeptin values for differentiation between CD and ectopic CS with the inferior petrosal sinus sampling (IPSS) after desmopressin injection,
Measured: During the IPSS
ACTH values during IPSS
Best fit of diagnostic ACTH values for differentiation between CD and ectopic CS with the inferior petrosal sinus sampling (IPSS) after desmopressin injection
Measured: 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
ROC AUC of the [18F]FET PET-MRI and IPSS in differentiating CD from ectopic CS Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the [18F]FET PET-MRI and IPSS for differentiation between CD and ectopic CS
Measured: Follow-up data 3-6 months post-treatment
Exact localization of small functional PitNETs in patients with CD using the [18F]FET PET-MRI
Stated as left, central or right side, assessed by an experienced nuclear medicine physician and neuroradiologist Sensitivity, specificity, PPV and NPV of the [18F]FET PET-MRI for the exact localization of small functional PitNETs in patients with CD
Measured: perioperative
Exact localization of small functional PitNETs in patients with CD using the inferior petrosal sinus sampling (IPSS)
Sensitivity, specificity, PPV and NPV of the IPSS for the exact localization of small functional PitNETs in patients with CD
Measured: perioperative
Exact localization of small functional PitNETs in patients with CD using the structural MRI
Sensitivity, specificity, PPV and NPV of the structural MRI for the exact localization of small functional PitNETs in patients with CD
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start4 Jun 2026
- Primary completion30 Jul 2029 (estimated)
- Study completion30 Jul 2029 (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 University Hospital, Basel, SwitzerlandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108244
- Sponsor's protocol ID
- FIND study
- Acronym
- FIND
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of [18F]FET PET-MRI to Improve Detection of Pituitary Adenomas in Cushing's Disease - a Prospective Diagnostic Study
- ClinicalTrials.gov ID
- NCT07108244
- Acronym / sponsor ID
- FIND / FIND study
- Conditions
- Cushing Disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 6 Aug 2025 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]FET-PET-MRI vs IPSS for diagnosing CD vs ectopic CS in ACTH-dependent cases | Other | Diagnostic Test: [18F]FET PET-MRIParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| [18F]FET PET-MRIAll 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 participant to guide further clinical management. | Diagnostic test | [18F]FET-PET-MRI vs IPSS for diagnosing CD vs ectopic CS in ACTH-dependent cases |
Primary outcome
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.
The difference in the proportion of correct distinction between CD and ectopic CS in patients with ACTH-dependent hypercortisolism using [18F]FET PET-MRI versus IPSS
6 secondary outcomes
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
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 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]FET PET-MRI in people with Cushing Disease, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
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 8 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Switzerland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 6 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.