Ga-68-DOTATOC -PET in the Management of Pituitary Tumours
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- SUV max in GA-68 DOTATOC in pituitary tumours in comparison to normal pituitary
研究概览
简要总结
Title: Gallium (GA) -68-DOTATOC -PET (positron emission tomography) in the management of pituitary tumours Medical product: Ga-68-DOTATOC in PET/computer tomography (CT) Route of administration: Intravenously Diseases of interest: Pituitary tumours Aim: To study the detection of pituitary tumours with Ga-68-DOTATOC -PET (Ga-PET) and to correlate the tracer expression to somatostatin receptor (sst) occurrence Study design: Prospective non-randomised case-control study with open design with GA-PET before and after pituitary surgery in patients with pituitary tumours Study population: patients with acromegaly (n=10), Cushing's' disease of pituitary origin (n=10), TSH (thyreotropin) producing tumours (TSHomas) (n=5) and non-functioning pituitary adenomas (NFPA) (n=20) Number of patients: 45 Inclusion criteria: Adult man or woman (over 18 years) and naïve, unoperated pituitary tumour with growth hormone (GH) or adrenocorticotrophic hormone (ACTH)) or TSH production or NFPA without treatment with somatostatin analogues (SSA) or dopamine agonists.
Exclusion criteria: Patient who may not attend to the protocol according to the investigators opinion. Pregnancy or lactating. Isolated prolactin producing tumours. Overproduction of gonadotropins. Carcinoids ie ectopic corticotrophin realising factor (CRF) production. Known or suspected allergy to the trial product or related products.
Controls: Adult patients with Thyroid associated ophthalmopathy (TAO) before iv steroid infusion (part of another study see this protocol)- Study variables: Tumour detection, Tracer uptake as Standardised uptake value (SUV) max (SUVmax), SUV hotspot and SUV mean in regions of interests (ROIs) Time schedule: Recruitment of patients 2015-2017. Study termination 3 years later
详细描述
Background The most common cause to pituitary insufficiency is the pituitary adenoma (PA). PA may be divided into hormone producing PAs and non-functioning PAs (NFPA). Normal pituitary tissue, as well as tissues from PAs, expresses somatostatin receptors (sst). Five subtypes of sst receptors has been characterized.
Magnetic resonance tomography (MRI) presents anatomy, while in vivo diagnostics with somatostatin receptor scintigraphy (SRS) or position emission tomography (PET) reflect the functional properties of the tissue. The SRS have earlier been evaluated for diagnostics of pituitary diseases and has low discriminative ability to differ tumor tissue from normal pituitary tissue even though some secretory tumors and NFPA are seen. The superiority of the PET in diagnostics compared to the SRS is based on higher spatial resolution and a higher tumor to background ratio. Therefore it is of large interest to study Gallium 68 DOTATOC (Ga-PET) i small tumours that exhibit sst, such as in the pituitary, where high resolution is essential to discriminate from normal tissue and to evaluated residual tumor tissue postoperatively.
Aim with the project
To evaluate Ga-PET in the management of pituitary tumors and to seek the answer to the following questions:
- Is the method of value in primary diagnostics in PAs? Does Ga-PET contribute with more functional information than that given from an conventional MRI?
- Is the method of value in the follow-up, the detection of residual tumor tissue, and increase the possibility to differ scar tissue from true tumor?
- Can relapses of PA be detected earlier with Ga-PET than with conventional MRI?
- Are some of the sub-groups easier to detect that others??
- Can the pathological-anatomical findings and the immunochemical expression of sst be correlated to the PET findings?
- Can the treatment with somatostatin analogues be designed from the PET investigation and the sst analysis?
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
- •Naïve, unoperated pituitary tumour with GH or ACTH or TSH production or NFPA without treatment with somatostatin analogues or dopamine agonists.
排除标准
- •Patient who may not attend to the protocol according to the investigators opinion.
- •Pregnancy or lactating
- •Isolated prolactin producing tumours
- •Overproduction of gonadotrophins
- •Carcinoids ie ectopic CRF production
- •Known or suspected allergy to the trial product or related products.
研究组 & 干预措施
Ga-68 DOTATOC PET in pituitary adenomas
To give Ga-68 DOTATOC in pituitary patients doing PET/CT
They are compared with Ga-68 DOTATOC PET performed in another study on patients with no pituitary disease.
干预措施: Gallium-68 DOTATOC PET (Drug)
结局指标
主要结局
SUV max in GA-68 DOTATOC in pituitary tumours in comparison to normal pituitary
时间窗: measured at 36 months +/- 2 weeks from baseline
Maximum Standardized Uptake Value
次要结局
- Ga-PET uptake in correlation to sst expression in pituitary tumours, measured as SUVmax which is then used to establish statistical relationship with a cell membrane-based sst-immunohistochemistry (IHC) score"(measured at 36 months +/- 2 weeks from baseline)
- Adverse event registration in association to Ga-68 PET(measured at 36 months +/- 2 weeks from baseline)
- Detection of tumour recurrence with Ga-PET(measured at 36 months +/- 2 weeks from baseline)