Al18F-NOTA-octreotide PET Imaging of the Somatostatin Receptor in Neuroendocrine Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Differential detection ratio (DDR)
研究概览
简要总结
The aim of this study is to evaluate the diagnostic performance of Al18F-NOTA-octreotide PET imaging in comparison with the current golden standard, 68Ga-DOTA-somatostatin analog PET, in neuroendocrine tumor patients.
详细描述
Part A (main part of the trial):
Seventy-five neuroendocrine tumor (NET) patients (M/F, aged 18 years and older) with a routine clinical 68Ga-DOTA-somatostin analog (SSA) PET/CT performed in the last three months or scheduled within three months, will undergo a whole-body Al18F-NOTA-octreotide PET/CT.
Part B:
At least 10, possibly up to 20 NET patients (M/F, aged 18 years and older) with a routine clinical 68Ga-DOTA-SSA PET/CT performed in the last three months or scheduled within three months, will undergo a whole-body Al18F-NOTA-octreotide PET/MR.
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
- •Subject is aged over 18 years.
- •Signed Informed Consent.
- •Subject is diagnosed with a histologically and/or cytologically confirmed neuroendocrine tumor of all grades of gastroenteropancreatic, pulmonary, neural crest or unknown primary origin.
- •Subject should have at least one known tumoral lesion below the level of the submandibular and parotid glands with either a minimum size of 1 cm in at least one dimension on morphological imaging (CT, MRI, ultrasound), or a maximal standardized uptake value (SUVmax) of at least 10 on 68Ga-DOTA-SSA PET, in both cases performed within 4 months prior to study scan. A positive lesion is defined as a volume of increased tracer uptake compared to background, deemed to be caused by the presence of NET cells, and that is unlikely to be attributed to physiological or benign etiology (e.g. inflammation, blood pool retention, excretion, etc.).
- •Subject should have a routine clinical 68Ga-DOTA-SSA PET/CT performed within three months prior to the study scan or scheduled within three months after the study scan.
- •Female subjects should be (a) post-menopausal, or (b) surgically sterile, or (c) using effective contraceptive with negative pregnancy test.
排除标准
- •Part A and B:
- •Subject has a previous or ongoing recurrent or chronic disease, other than a neuroendocrine tumor, at high risk to interfere with the performance or evaluation of the trial according to the judgement of the investigator.
- •Subject has had exposure to ionizing radiation (> 1 mSv) in other research studies within the last 12 months.
- •Subject has recently (< 30 days or 5 times the plasma half-life of the investigated drug, whichever is longest) participated or is simultaneously participating in another prospective interventional clinical trial.
- •Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e. weight lifting, running, bicycling) beginning 4 days prior to tracer injection up to 1 day after tracer injection.
- •Subject is potentially pregnant (urinary hCG test can be performed in case of doubt) or is breast-feeding.
- •Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator.
- •Subject does not understand the study procedure.
- •Subject is mentally or legally incapacitated.
- •Only for part B:
- •Subject has a contra-indication for MR scanning.
- •Subject suffers from claustrophobia or cannot tolerate confinement during PET/MR scanning.
- •Subject has an impaired renal function: estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m² (the last known value may not date from more than 3 months prior to the study PET/MR; if not available a blood analysis may be performed as part of the trial).
- •Subject suffers from diseases for which butylhyoscine bromide (Buscopan®) is contra-indicated: glaucoma, paralytic ileus, severe colitis ulcerosa or myasthenia gravis.
研究组 & 干预措施
Patients
In the main part of the trial (part A) 75 patients with cytologically and/or histologically confirmed neuroendocrine tumors of all grades of gastroenteropancreatic, pulmonary, neural crest or unknown primary origin will receive a single intravenous injection of Al18F-NOTA-octreotide. At two hours after tracer injection they will undergo a whole-body PET/CT scan.
In part B of the trial 10 up to 20 patients with with cytologically and/or histologically confirmed neuroendocrine tumors of all grades of gastroenteropancreatic, pulmonary, neural crest or unknown primary origin will receive a single intravenous injection of Al18F-NOTA-octreotide. At two hours after tracer injection they will undergo a whole-body PET/MR scan.
干预措施: Al18F-NOTA-octreotide (Drug)
Patients
In the main part of the trial (part A) 75 patients with cytologically and/or histologically confirmed neuroendocrine tumors of all grades of gastroenteropancreatic, pulmonary, neural crest or unknown primary origin will receive a single intravenous injection of Al18F-NOTA-octreotide. At two hours after tracer injection they will undergo a whole-body PET/CT scan.
In part B of the trial 10 up to 20 patients with with cytologically and/or histologically confirmed neuroendocrine tumors of all grades of gastroenteropancreatic, pulmonary, neural crest or unknown primary origin will receive a single intravenous injection of Al18F-NOTA-octreotide. At two hours after tracer injection they will undergo a whole-body PET/MR scan.
干预措施: PET/CT (Device)
Patients
In the main part of the trial (part A) 75 patients with cytologically and/or histologically confirmed neuroendocrine tumors of all grades of gastroenteropancreatic, pulmonary, neural crest or unknown primary origin will receive a single intravenous injection of Al18F-NOTA-octreotide. At two hours after tracer injection they will undergo a whole-body PET/CT scan.
In part B of the trial 10 up to 20 patients with with cytologically and/or histologically confirmed neuroendocrine tumors of all grades of gastroenteropancreatic, pulmonary, neural crest or unknown primary origin will receive a single intravenous injection of Al18F-NOTA-octreotide. At two hours after tracer injection they will undergo a whole-body PET/MR scan.
干预措施: PET/MR (Device)
结局指标
主要结局
Differential detection ratio (DDR)
时间窗: 2 years
The fraction of lesions detected by one tracer is the detection ratio. In case of non-inferiority, the difference in detection ratio on Al18F-NOTA-octerotide PET and the detection ratio on 68Ga-DOTA-SSA PET, i.e. the differential detection ratio (DDR), equals zero. The primary objective will be met if the lower margin of the 95% confidence interval for the DDR is higher than -15%. Readers will be blinded for the radiopharmaceutical that is used. (only for part A of the trial)
次要结局
- Overall diagnostic image quality according to a five-point Likert-scale(3 years)
- Lesion detection rate on the organ level(2 years)
- Lesion uptake(2 years)
- Clinical impact on TNM staging or patient management(2.5 years)
- Lesion detection rate according to the specific 68Ga-DOTA-SSA used for the routine PET scan(2 years)
- Lesion detection rate according to tumor grade(2 years)
- Lesion conspicuity according to a five-point Likert-scale(3 years)
- Diagnostic confidence according to a five-point Likert-scale(3 years)
- Whole-body MRI correlate of the lesions detected by the PET scans(2.5 years)
- Effect of Al18F-NOTA-octreotide injection on blood pressure(2 years)
- Effect of Al18F-NOTA-octreotide injection on heart rate(2 years)