The FIND study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

Decision date (initial)

2025-05-15

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

The main objective is to compare the proportion of patients with ACTH-dependent hypercortisolism in whom Cushing's disease (CD) is correctly differentiated from ectopic Cushing's syndrome (CS) using [18F]FET PET-MRI compared to IPSS.

Secondary objectives 1

1. Secondary objectives include the analysis of the diagnostic accuracy of [18F]FET-PET-MRI, IPSS and structural MRI for the exact localisation of small functional PitNETs in patients with CD, the assessment of postoperative CD outcomes, and the evaluation of copeptin as a diagnostic marker in the evaluation of CD.

Conditions and MedDRA coding

ACTH-dependent hypercortisolism

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Age ≥18 years 2. 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; and/or Elevated late night salivary cortisol (min. 2/3 measurements); and/or Elevated 24-hours urinary free cortisol (min. 2 measurements) 3. Pituitary microadenoma (< 10mm) OR negative / inconclusive findings on standard MRI of the pituitary sella-region. 4. Indication for further evaluation with IPSS.

Exclusion criteria 1

1. A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Non-ACTH dependent hypercortisolism; 2. Pituitary macroadenoma (≥ 10mm); 3. Suspicion of Pseudo-Cushing’s disease (e.g. due to alcohol use disorder, PCO’s, obesity, depression) according to standard work up / guidelines; 4. Use of glucocorticosteroids; 5. Impaired renal function, defined as eGFR (MDRD) <30ml/min/1,73 m2. An exception can be made in consultation with the treating physician; 6. Impaired Liver function; 7. Pregnancy/breastfeeding. For the latter, temporary discontinuation may be considered; 8. Known allergic reaction to therapeutic radiopharmaceuticals; 9. Inability to lie still in supine position for the duration of the PET-MRI scan; 10. • Other conditions that make it impossible to perform a PET-MRI scan, such as neurological disease, severe immobility, or unsuppressable claustrophobia.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of this prospective evaluation is the difference in the proportion of patients with ACTH-dependent hypercortisolism in whom CD is correctly distinguished from ectopic CS using [18F]FET PET-MRI versus IPSS. [18F]FET PET-MRI will be compared for non-inferiority to the current standard IPSS.

Secondary endpoints 1

1. Secondary endpoints include the sensitivity, specificity, positive and negative predictive value of the two techniques for the exact localization of ACTH-secreting PitNETs, based on post-operative neurosurgery and pathology reports as well as biochemical remission as reference standards. The area under the curve (AUC) for both techniques will be calculated from the receiver operating curve (ROC).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Sponsor organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Address

Dr. Molewaterplein 40

City

Rotterdam

Postcode

3015 GD

Country

Netherlands

Scientific contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

drs. R. van der Groef

Public contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

drs. R. van der Groef

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications