18F-fluoro-ethyl-tyrosine (18FET) PET for Difficult Clinical Situations in Functional Pituitary Adenoma. A Prospective, Single Arm, Single Center Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
研究组 & 干预措施
Patients
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.
干预措施: fluoroethyl-L tyrosine (18F) (Drug)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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.(2 months +/- 2 months)
- Describe SUVmax based on the 18FET PET scan result(2 months +/- 2 months)
- Describe Adenoma/healthy brain ratio based on the 18FET PET scan result(2 months +/- 2 months)
- Describe kinetic parameters based on the 18FET PET scan result.(2 months +/- 2 months)
- Measure the concordance of the 18FET PET scan results between three readers.(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).(1 year +/- 2 months)