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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluoroethyl-L tyrosine (18F) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months +/- 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months +/- 2 months |
| Describe SUVmax based on the 18FET PET scan result |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin CHEVALIER, MD | Contact | 3.20.44.64.19 | +33 | benjamin.chevalier@chu-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Benjamin CHEVALIER, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roger Salengro Hospital - Lille University Hospital | Lille | 59037 | France |
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| ID | Term |
|---|---|
| C545932 | (18F)fluoroethyltyrosine |
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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). |
| 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). | 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). | 2 months +/- 2 months |
| Measure the concordance of the 18FET PET scan results between three readers. | Concordance will be measured by the Krippendorf coefficient. | 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. | 1 year +/- 2 months |