Functional Pituitary AdenomasPhase 2FET-PITNCT07360548
Study of 18FET PET in Functional Pituitary Adenomas With Indeterminate MRI Findings
A Phase 2 study testing fluoroethyl-L tyrosine (18F) in people with Functional Pituitary Adenomas, run by University Hospital, Lille at 1 site in France.
Trial summary
Pituitary adenomas (PAs) are common benign tumors, but their potential for tumor aggression and hormone secretion make them serious tumors. In particular, patients with secreting tumors [prolactinomas (prolactin secretion), acromegaly (growth hormone), Cushing's disease (ACTH), thyrotropic adenomas (TSH)] have… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Pituitary Adenomas
- What is being tested?
- fluoroethyl-L tyrosine (18F)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Sep 2030
- Phase
- Phase 2
- 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
- Male and/or female
- Aged 18 years or older
- Suspected of having a functional pituitary adenoma (prolactinoma - Cushing's disease - acromegaly - thyrotropic adenoma), de novo or recurrence/persistence
- With indeterminate pituitary MRI
- Patient covered by social security
- Patient willing to comply with all study procedures and duration
- Patient eligible for surgery and/or radiotherapy in case of positive 18FET PET scan
Who cannot join
- Pregnancy
- Known hypersensitivity to radiopharmaceuticals
- Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system, refusal to sign the consent form
- Contraindication to surgery and radiotherapy in the case of positive 18FET PET
- Patients who are active alcohol users
- Patients suffering from liver disease or severe uncontrolled epilepsy
- Patients deprived of their liberty (guardianship, curatorship, etc.)
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
Roger Salengro Hospital - Lille University Hospital
Lille, 59037
DRS, 3 20 44 41 45 ext. +33, drs.promotion@chu-lille.fr
About this study
Official title: 18F-fluoro-ethyl-tyrosine (18FET) PET for Difficult Clinical Situations in Functional Pituitary Adenoma. A Prospective, Single Arm, Single Center Study
Pituitary adenomas (PAs) are common benign tumors, but their potential for tumor aggression and hormone secretion make them serious tumors. In particular, patients with secreting tumors [prolactinomas (prolactin secretion), acromegaly (growth hormone), Cushing's disease (ACTH), thyrotropic adenomas (TSH)] have increased morbidity and mortality. They may be small and/or undetectable by magnetic resonance imaging (MRI), the current gold standard for morphological evaluation of pituitary lesions. The diagnosis of recurrence in a patient who has already undergone surgery also raises the problem of distinguishing between a lesion and postoperative remodeling. The detection of these tumors therefore represents a significant challenge in guiding therapeutic management.Nuclear medicine could solve this challenge, particularly radiopharmaceuticals (MRPs) used in PET (positron emission tomography) combined with CT scans. A few studies have evaluated MRPs in the context of APs, with those targeting amino acid metabolism proving to be the most promising, particularly carbon-11-labeled methionine (11C-MET). In retrospective studies only, 11C-MET PET has shown excellent performance in all situations where MRI fails (detection rate >80%), but the extremely short half-life of 11C requires heavy infrastructure, limiting its access in routine clinical practice.18Fluoroethyl-Tyrosine (18FET) is also a PET MRP targeting amino acid metabolism used in France in neuro-oncology with performance equivalent to 11C-MET, and which has the advantage of being available daily in all nuclear medicine centers.
The performance of 18FET in APs is almost unknown, with only two retrospective studies recently published, including 22 patients with Cushing's disease on the one hand and 17 patients with prolactinoma on the other: The detection rates were particularly interesting (82% and 100% respectively), but it is imperative to confirm these data prospectively and to evaluate the performance of this MRP in other functional types, which is therefore the purpose of this study.
- Conditions
- Functional Pituitary Adenomas
- Being tested
- fluoroethyl-L tyrosine (18F)
- Keywords
- PET-18 Fluoro ethyl tyrosine, Functional pituitary adenoma, Indeterminate MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluoroethyl-L tyrosine (18F)Drug
Also called IASOglio 2 GBq/mL : Marketing authorization number : 34009 550 105 1 7 (15mL) / 34009 550 105 2 4 (25 mL)
The protocol consists of a single arm involving the administration of the radiopharmaceutical 18FET (IASOglio).
This will be administered once during the study, directly intravenously with an activity of 200 +/- 15MBq, as recommended by the European EANM/EANO/RANO guidelines and used in retrospective studies investigating the contribution of 18FET in AP. Included patients will have fasted for at least 4 hours beforehand. PET image acquisition will begin as soon as the radiopharmaceutical is injected.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | The investigative procedure used is 18FET PET, which will be the only difference from the usual care.
The study data (clinical observations, laboratory results, imaging results) will be collected by the various study investigators during a consultation and/or via the Lille University Hospital computer server.
Performance of the 18FET PET scan in the Nuclear Medicine Department. The experimental drug is [18F]Fluoroethyl-L-tyrosine, produced in accordance with Good Manufacturing Practices (GMP) guidelines and marketed under the name IASOglio by Curium PET France. The maximum activity for an adult is to 250 MBq. This activity must be administered by direct intravenous injection.
Shelf life: 14 hours from the end of synthesis. After first use or after dilution, the product can be stored for up to 8 hours without exceeding the expiry date of 14 hours from the end of synthesis. Receives: Drug: fluoroethyl-L tyrosine (18F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the ability of 18FET PET to detect functional pituitary adenomas in patients with de novo, recurrent, or persistent functional AP when pituitary MRI is non-contributive.
Frequency of patients for whom PET would be useful among patients with a positive 18FET PET result.The gold standard will be defined by the pathological examination of the surgical specimen in the case of surgery, or by the possibility of stopping or gradually reducing medical treatment while maintaining normalized hormone secretion in the case of radiotherapy.
Measured: 2 months +/- 2 months
Secondary outcomes (6)
Describe the frequency of patients positive for 18FET PET in patients with de novo, recurrent, or persistent functional AP when pituitary MRI is non-contributive.
Frequency of patients with positive 18FET PET scans.
Measured: 2 months +/- 2 months
Describe SUVmax based on the 18FET PET scan result
SUVmax (g/mL) based on the result of the 18FET PET scan (patients negative on the 18FET PET scan, patients positive on the 18FET PET scan and successfully treated, and patients positive on the 18FET PET scan but not treated or treatment failure).
Measured: 2 months +/- 2 months
Describe Adenoma/healthy brain ratio based on the 18FET PET scan result
Based on the result of the 18FET PET scan (patients negative on the 18FET PET scan, patients positive on the 18FET PET scan and successfully treated, and patients positive on the 18FET PET scan but not treated or treatment failure).
Measured: 2 months +/- 2 months
Describe kinetic parameters based on the 18FET PET scan result.
Kinetic parameters (time to peak in minutes) based on the result of the 18FET PET scan (patients negative on the 18FET PET scan, patients positive on the 18FET PET scan and successfully treated, and patients positive on the 18FET PET scan but not treated or treatment failure).
Measured: 2 months +/- 2 months
Measure the concordance of the 18FET PET scan results between three readers.
Concordance will be measured by the Krippendorf coefficient.
Measured: 2 months +/- 2 months
Describe the proportion of patients who, following 18FET PET, received therapeutic treatment targeting the adenoma (surgery and/or external radiation therapy).
Frequency of patients undergoing surgery and frequency of patients undergoing radiation therapy among patients who tested positive on 18FET PET scans.
Measured: 1 year +/- 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Pituitary AdenomasStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin CHEVALIER, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360548
- Sponsor's protocol ID
- 2025_0205
- Acronym
- FET-PIT
- Status last verified
- Apr 2026
- First submitted
- 10 Dec 2025
- Last updated
- 6 May 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 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-fluoro-ethyl-tyrosine (18FET) PET for Difficult Clinical Situations in Functional Pituitary Adenoma. A Prospective, Single Arm, Single Center Study
- ClinicalTrials.gov ID
- NCT07360548
- Acronym / sponsor ID
- FET-PIT / 2025_0205
- Conditions
- Functional Pituitary Adenomas
- Keywords
- PET-18 Fluoro ethyl tyrosine, Functional pituitary adenoma, Indeterminate MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 22 Jan 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.
Pituitary adenomas (PAs) are common benign tumors, but their potential for tumor aggression and hormone secretion make them serious tumors. In particular, patients with secreting tumors [prolactinomas (prolactin secretion), acromegaly (growth hormone), Cushing's disease (ACTH), thyrotropic adenomas (TSH)] have increased morbidity and mortality. They may be small and/or undetectable by magnetic resonance imaging (MRI), the current gold standard for morphological evaluation of pituitary lesions. The diagnosis of recurrence in a patient who has already undergone surgery also raises the problem of distinguishing between a lesion and postoperative remodeling. The detection of these tumors therefore represents a significant challenge in guiding therapeutic management.Nuclear medicine could solve this challenge, particularly radiopharmaceuticals (MRPs) used in PET (positron emission tomography) combined with CT scans. A few studies have evaluated MRPs in the context of APs, with those targeting amino acid metabolism proving to be the most promising, particularly carbon-11-labeled methionine (11C-MET). In retrospective studies only, 11C-MET PET has shown excellent performance in all situations where MRI fails (detection rate >80%), but the extremely short half-life of 11C requires heavy infrastructure, limiting its access in routine clinical practice.18Fluoroethyl-Tyrosine (18FET) is also a PET MRP targeting amino acid metabolism used in France in neuro-oncology with performance equivalent to 11C-MET, and which has the advantage of being available daily in all nuclear medicine centers.
The performance of 18FET in APs is almost unknown, with only two retrospective studies recently published, including 22 patients with Cushing's disease on the one hand and 17 patients with prolactinoma on the other: The detection rates were particularly interesting (82% and 100% respectively), but it is imperative to confirm these data prospectively and to evaluate the performance of this MRP in other functional types, which is therefore the purpose of this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Drug: fluoroethyl-L tyrosine (18F)The investigative procedure used is 18FET PET, which will be the only difference from the usual care. The study data (clinical observations, laboratory results, imaging results) will be collected by the various study investigators during a consultation and/or via the Lille University Hospital computer server. Performance of the 18FET PET scan in the Nuclear Medicine Department. The experimental drug is [18F]Fluoroethyl-L-tyrosine, produced in accordance with Good Manufacturing Practices (GMP) guidelines and marketed under the name IASOglio by Curium PET France. The maximum activity for an adult is to 250 MBq. This activity must be administered by direct intravenous injection. Shelf life: 14 hours from the end of synthesis. After first use or after dilution, the product can be stored for up to 8 hours without exceeding the expiry date of 14 hours from the end of synthesis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and/or female
- Aged 18 years or older
- Suspected of having a functional pituitary adenoma (prolactinoma - Cushing's disease - acromegaly - thyrotropic adenoma), de novo or recurrence/persistence
- With indeterminate pituitary MRI
- Patient covered by social security
Key exclusion criteria (7 listed)
- Pregnancy
- Known hypersensitivity to radiopharmaceuticals
- Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system, refusal to sign the consent form
- Contraindication to surgery and radiotherapy in the case of positive 18FET PET
- Patients who are active alcohol users
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 |
|---|---|---|
| fluoroethyl-L tyrosine (18F)Also: IASOglio 2 GBq/mL : Marketing authorization number : 34009 550 105 1 7 (15mL) / 34009 550 105 2 4 (25 mL)The protocol consists of a single arm involving the administration of the radiopharmaceutical 18FET (IASOglio). This will be administered once during the study, directly intravenously with an activity of 200 +/- 15MBq, as recommended by the European EANM/EANO/RANO guidelines and used in retrospective studies investigating the contribution of 18FET in AP. Included patients will have fasted for at least 4 hours beforehand. PET image acquisition will begin as soon as the radiopharmaceutical is injected. | Drug | Patients |
Primary outcome
Describe the ability of 18FET PET to detect functional pituitary adenomas in patients with de novo, recurrent, or persistent functional AP when pituitary MRI is non-contributive.
Time frame: 2 months +/- 2 months
Frequency of patients for whom PET would be useful among patients with a positive 18FET PET result.The gold standard will be defined by the pathological examination of the surgical specimen in the case of surgery, or by the possibility of stopping or gradually reducing medical treatment while maintaining normalized hormone secretion in the case of radiotherapy.
6 secondary outcomes
Describe the frequency of patients positive for 18FET PET in patients with de novo, recurrent, or persistent functional AP when pituitary MRI is non-contributive.
Time frame: 2 months +/- 2 months
Describe SUVmax based on the 18FET PET scan result
Time frame: 2 months +/- 2 months
Describe Adenoma/healthy brain ratio based on the 18FET PET scan result
Time frame: 2 months +/- 2 months
Describe kinetic parameters based on the 18FET PET scan result.
Time frame: 2 months +/- 2 months
Measure the concordance of the 18FET PET scan results between three readers.
Time frame: 2 months +/- 2 months
Describe the proportion of patients who, following 18FET PET, received therapeutic treatment targeting the adenoma (surgery and/or external radiation therapy).
Time frame: 1 year +/- 2 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 6 May 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.
Benjamin CHEVALIER, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluoroethyl-L tyrosine (18F) in people with Functional Pituitary Adenomas, run by University Hospital, Lille 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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 May 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Benjamin CHEVALIER, MD (3.20.44.64.19 ext. +33, benjamin.chevalier@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the ability of 18FET PET to detect functional pituitary adenomas in patients with de novo, recurrent, or persistent functional AP when pituitary MRI is non-contributive. (time frame: 2 months +/- 2 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 6 May 2026.