2025-523829-17-00招募中2 期
18F-fluoro-ethyl-tyrosine (18FET) PET for difficult clinical situations in functional pituitary adenoma. A prospective, single arm, single center study. (FET-PIT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male and/or female
- •Aged 18 years or older
- •Suspected 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
- •Known hypersensitivity to radiopharmaceuticals
- •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
- •Patient with active alcohol consumption
- •Patients suffering from liver disease or severe uncontrolled epilepsy
- •Patients deprived of their liberty (guardianship, curatorship, etc.)
- •Patients who do not speak French
研究组 & 干预措施
IASOglio 2 GBq/mL, solution injectable, IASOglio 2 GBq/mL, solution injectable
Test
干预措施: IASOglio 2 GBq/mL, solution injectable (Drug)
结局指标
主要结局
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.
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.
次要结局
- 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.
- Proportion of patients with a negative 18FET PET scan who underwent exploratory surgery during the 12-month study period.
- 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.
- 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.
- 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).
- Inter-reader agreement in the assessment of 18FET PET positivity, as measured by Krippendorff’s alpha coefficient.
研究者
CHEVALIER Benjamin
Scientific
Centre Hospitalier Universitaire De Lille
研究点 (1)
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