跳至主要内容
临床试验/NCT02078843
NCT02078843终止1 期

Diagnostic Accuracy of Gallium-68-DOTATATE PET/CT Compared to Indium-111-pentetreotide Scintigraphy (SPECT/CT) for Gastroenteropancreatic Neuroendocrine Tumors

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
终止
入组人数
54
试验地点
1
主要终点
Number of patients correctly identified as not having GEP-NET by using Gallium-68-DOTATATE PET/CT and Indium-111-pentetreotide scintigraphy (SPECT/CT)

研究概览

简要总结

The investigators hypothesize that the new imaging method Gallium-68-DOTATATE has a higher diagnostic value in the detection of neuroendocrine tumors than the established imaging method Indium-111-Octreoscan. Therefore, the investigators will perform both imaging procedures in patients with suspected or confirmed neuroendocrine tumors. Subsequently, the investigators will compare the diagnostic performance of both methods.

详细描述

Background

Neuroendocrine tumors Neuroendocrine tumors (NET) are heterogeneous slow-growing neoplasms, occurring in 1-4/100,000 people per year. They origin from endocrine cells that derive from entodermal stem cells and are characterized by an endocrine metabolism and a typical pathologic pattern.

Slow metabolic rates of NET, small lesion size and variable anatomical localization have represented the major limits for lesions diagnosis. The diagnostic workup for NET has relied on conventional morphological imaging procedures including computed tomography (CT), ultrasound (US) and magnetic resonance imaging (MRI) combined with gamma camera functional imaging, namely whole-body somatostatin receptor scintigraphy (SRS). SRS show a higher diagnostic accuracy than CT for NET diagnosis at both the primary and metastatic site, but there is still room for improvement. Novel PET tracers specifically developed for NET may increase diagnostic accuracy considerably as outlined below.

Somatostatin receptor scintigraphy (SRS) As NET have high affinity somatostatin receptors, scintigraphic methods have been developed in the early nineties to allow in vivo imaging. SRS using Indium-111-DTPA-octreotide (Indium-111-pentetreotide scintigraphy), is the most widely used diagnostic test. Although rather sensitive and helpful for whole body staging compared to traditional imaging methods, this technique has pitfalls, one of them being the poor spatial resolution, leading to the development of PET-based imaging.

Gallium-68-DOTA-peptide PET In the past decade, several positron emitting tracers have been developed for NET imaging. 68Ga-DOTA-peptides are a group of PET tracers that specifically bind to somatostatin receptors (SSTR) over-expressed on NET cells. Gallium-68-DOTA-peptides structure can be summarized in (1) the active part binding to SSTR (TOC, NOC, TATE), (2) the chelant (DOTA) and (3) the isotope (68Ga). Indications to perform 68Ga -DOTA-peptides studies in NET patients include: staging, re-staging after therapy, identification of the site of the unknown primary tumor in patients with proven NET secondary lesions and selection of cases eligible for therapy with somatostatin analogues.

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

入选标准

  • Age ≥ 18 years
  • Signed written informed consent with full understanding of the study procedures and the investigational nature of the study
  • Patient referred to Indium-111-pentetreotide scintigraphy., which was performed as part of clinical routine care
  • Inclusion criteria specific for cases only
  • Histologically established GEP-NET (new or recurrent)
  • Tumor mass remaining after initial biopsy or surgery
  • Inclusion criteria specific for controls only
  • Suspicion of any NET (new or recurrent) but no established diagnosis or established diagnosis of any NET (new or recurrent) but no remaining tumor mass after surgery
  • Exclusion Criteria
  • Previous inclusion in the same study with the following exception: a patient may be included as case if she/he was previously included as control
  • Gastric type 2 ECL cell neuroendocrine tumors
  • Pregnant or nursing women
  • Known intolerance to any protocol required diagnostic intervention
  • Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly
  • Exclusion criteria specific for controls only
  • Patients for whom it remains unclear whether the tumor was completely removed

排除标准

  • 未提供

研究组 & 干预措施

All patients

Other

Subsequent performance of index test and standard test

干预措施: Gallium-68-DOTATATE PET/CT (index test) (Drug)

All patients

Other

Subsequent performance of index test and standard test

干预措施: Indium-111-Octreoscan (standard test) (Drug)

结局指标

主要结局

Number of patients correctly identified as not having GEP-NET by using Gallium-68-DOTATATE PET/CT and Indium-111-pentetreotide scintigraphy (SPECT/CT)

时间窗: 6 months

Number of patients correctly identified as having GEP-NET by using Gallium-68-DOTATATE PET/CT and Indium-111-pentetreotide scintigraphy (SPECT/CT)

时间窗: 6 months

次要结局

  • Number of patients with adverse events(6 months)
  • Patient satisfaction(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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