Study of 18FET PET in functional pituitary adenomas with indeterminate MRI findings

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Lille

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Decision date (initial)

2026-07-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AAP GIRCI Nord-Ouest 2024 · Curium PET France

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

Estimate the positivity rate using 18FET PET in patients with de novo, recurrent, or persistent functional AP who are eligible for adenoma-targeted treatment (surgery and/or external beam radiation therapy) and have non-contributory pituitary MRI

Secondary objectives 6

1. Describe the proportion of patients with positive 18FET PET results who received treatment targeting the adenoma (surgery and/or external beam radiation therapy) during the 12-month study period.
2. Describe the proportion of patients with negative 18FET PET results who underwent exploratory surgery during the 12-month study period.
3. Describe the response rate among patients who underwent surgery (adenoma-targeted in cases of positive 18FET PET and exploratory in cases of negative 18FET PET) during the 12-month study period.
4. Describe SUVmax, SUVmean, SUVpeak, the ratios of SUVmax in the adenoma to SUVmax in healthy brain tissue and SUVmean in the adenoma to SUVmean in healthy brain tissue, and kinetic parameters (activity-time curve, time to peak) in patients with 18FET PET -positive findings.
5. Describe the results of the 18FET PET scan according to the histological subtype of AP.
6. Assess the inter-reader reproducibility of the interpretation of 18FET PET positivity.

Conditions and MedDRA coding

Patients (male or female) ≥18 years old with Suspected functional pituitary adenoma (prolactinoma, Cushing's disease, acromegaly, thyrotropic adenoma), de novo or recurrence/persistence, With indeterminate pituitary MRI.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Male and/or female
2. Aged 18 years or older
3. Suspected functional pituitary adenoma (prolactinoma, Cushing's disease, acromegaly, thyrotropic adenoma), de novo or recurrence/persistence
4. With indeterminate pituitary MRI
5. Patient covered by social security
6. Patient willing to comply with all study procedures and duration
7. Patient eligible for surgery and/or radiotherapy in case of positive 18FET PET scan

Exclusion criteria 7

1. Pregnancy
2. Known hypersensitivity to radiopharmaceuticals
3. Administrative reasons: inability to receive informed consent, inability to participate in the entire study, lack of social security coverage, refusal to sign the consent form
4. Patient with active alcohol consumption
5. Patients suffering from liver disease or severe uncontrolled epilepsy
6. Patients deprived of their liberty (guardianship, curatorship, etc.)
7. Patients who do not speak French

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Prevalence of patients with positive 18FET PET, as determined by consensus among the three readers. PET positivity is defined as focal hyperuptake with an intensity greater than that of healthy cerebral and pituitary background signal.

Secondary endpoints 6

1. Proportion of patients with a positive 18FET PET scan who received treatment targeting the adenoma (surgery and/or external beam radiation therapy) during the 12-month study period.
2. Proportion of patients with a negative 18FET PET scan who underwent exploratory surgery during the 12-month study period.
3. The proportion of patients who responded to surgery performed during the 12-month study period, as defined by an improvement or normalization of laboratory parameters in accordance with the recommendations specific to each histological subtype.
4. SUVmax, SUVmean, SUVpeak, the ratios of SUVmax in the adenoma to SUVmax in healthy brain tissue and SUVmean in the adenoma to SUVmean in healthy brain tissue, as well as kinetic parameters (activity-time curve, time to peak) measured by 18FET PET.
5. Evaluation of 18FET PET results by histological subtype (prevalence of patients with positive 18FET PET, SUVmax, SUVmean, SUVpeak, the ratios of SUVmax in the adenoma to SUVmax in healthy brain tissue and SUVmean in the adenoma to SUVmean in healthy brain tissue, as well as kinetic parameters [activity-time curve, time to peak] measured by 18FET PET).
6. Inter-reader agreement in the assessment of 18FET PET positivity, as measured by Krippendorff’s alpha coefficient.

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Lille

Sponsor organisation

Centre Hospitalier Universitaire De Lille

Address

2 Avenue Oscar Lambret, Cs 70001 Cs 70001

City

Lille Cedex

Postcode

59037

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Lille

Contact name

CHEVALIER Benjamin

Public contact point

Organisation

Centre Hospitalier Universitaire De Lille

Contact name

CHEVALIER Benjamin

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 7 files

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

Application history

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