Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 11
- 主要终点
- Sensitivity to Correctly Diagnose NET
研究概览
简要总结
The primary goal of the analysis is to estimate the diagnostic accuracy of Gallium 68 (68Ga) -DOTATOC PET/CT for detecting neuroendocrine tumors (NETs) compared to conventional imaging techniques such as Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT). Participants with histologically and/or clinically confirmed and/or suspected NET will be enrolled.
详细描述
This is a prospective, Phase 2, single center study of participants with Neuroendocrine Tumors (NETs). Study participants will receive 68Ga-DOTATOC. DOTATOC is a somatostatin analogue that localizes on the somatostatin receptors expressed by NETs and is attached to a radioactive material called Gallium 68. Participants will undergo a PET/CT imaging study to investigate 68Ga-DOTATOC's suitability as a positron emission tomography (PET) imaging agent for NETs. The radiation (imaging) dose will be 111-185 megabecquerel (MBq) (3 - 5 mCi) ± 25%. All doses after labeling will be presented in buffered solution for intravenous injection. Imaging will start 90 ±30 minutes after injection.
Sensitivity and specificity of this imaging technique will be compared with those of conventional imaging modality including CT, MRI and In-111 Octreoscan performed within 6-12 months before or after PET/CT.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent.
- •Patients of either gender, aged ≥18 years.
- •Karnofsky status ≥
- •Life expectancy of at least 12 weeks.
- •Histologically and/or clinically confirmed and/or suspicious of NET.
- •A diagnostic CT or MRI of the tumour region or suspected area within the previous 12 weeks prior to dosing day is available.
- •Somatostatin-analogue scintigraphy scan with result (positive or negative) within the last 12 weeks.
- •Recent Blood test results up to 4-6 weeks as follows:
- •White Blood Cell (WBC): >2*109/L
- •Haemoglobin: >8.0g/Dl
- •Platelets: >50x109/L
- •Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline phosphatase (AP) each less than, or equal to, 5 times its Upper Limit of Normal (ULN)
- •Bilirubin less than, or equal to, three times its ULN
- •Serum creatinine: within normal range or <120μmol/L for patients aged 60 years or older.
- •Negative pregnancy test in women capable of child-bearing.
排除标准
- •Known hypersensitivity to Gallium 68, DOTATOC or to any of the excipients of 68Ga-DOTATOC.
- •Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (Long Acting Release) (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug.
- •Pregnant or breast-feeding women.
- •Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
研究组 & 干预措施
68Ga-DOTATOC PET/CT
Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.
干预措施: 68Ga-DOTATOC (Drug)
结局指标
主要结局
Sensitivity to Correctly Diagnose NET
时间窗: During imaging process ( approximately 120 minutes)
Sensitivity to detect NET will be assessed and compared with conventional imaging modality. Sensitivity is the ability of an agent to indicate the presence and location of NET. The ability of 68Ga-DOTATOC to localize more effectively to somatostatin receptors and the exquisite spatial resolution of PET/CT should make easier detection of primary and metastatic neuroendocrine tumors and allow better measurement of tumor burden. Sensitivity is the percentage of accurately diagnosed NET cases. All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) as standard care prior to 68Ga-DOTATOC imaging.
次要结局
- Specificity to Detect True Negative(During imaging process ( approximately 120 minutes))