An Open-label, Single-dose, Clinical Trial of 68Ga-DOTATATE (GalioMedix™) PET-CT Scan for Diagnosis of Primary and Metastatic Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Number of lesions detected by 68GA-DOTATATE compared to conventional imaging technique
研究概览
简要总结
To evaluate the concordance and discordance between results of 68Ga-DOTATATE PET-CT scan and OctreoScan ® which is considered standard of care diagnostic test for neuroendocrine cancers and other imaging modalities like CT scan/MRI as gold standard.
详细描述
The number of lesions that could be identified clearly as single foci will be determined for each patient. The same anatomic areas will be imaged with 68Ga-DOTATATE PET and 111In-penteoctreotide Scintigraphy to ensure relevant comparison of lesion detection. Because of confluence and inability to clearly delineate single liver lesions in some cases, liver metastases will be classified as 1 organ metastasis, independent of the number of liver metastases present. Lymph nodes smaller than 1 cm on CT or MRI and showing marked avidity for 68Ga- DOTATATE and 111In-penteoctreotide will be labeled as positive for disease. The presence of lesions will be confirmed by cross-sectional imaging of all patients with CT or MRI.
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
- •Signed informed consent
- •Subjects of either sex, aged ≥18 years
- •Histologically and/or clinically confirmed and/or suspected NET and/or A diagnostic imaging study including but not limited to CT or MRI or FDG PET/CT, NaF PET/CT, bone scan, ultrasound, etc. of the tumor region or suspected area within the 4 weeks of dosing day
- •Recent Blood test results (within 2-4 weeks predose) as WBC: ≥2 x 109/L, Haemoglobin: ≥8.0 g/dL, Platelets: ≥50 x 109/L, ALT, AST, AP:≤ 5 times ULN [ ULN for ALT, AST and AP is 70, 20 and 20 Units/I respectively], Bilirubin: ≤3 times ULN [ULN for total bilirubin is 1.3mg/dL]
- •Serum creatinine: Serum creatinine: <170 μmol/L
- •egative pregnancy test in women capable of child-bearing
排除标准
- •Known hypersensitivity to DOTA, to 68Gallium, to Octreotate or to any of the excipients of 68Ga-DOTATATE
- •Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (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-DOTATATE
All participants will be injected with 68Ga-DOTATATE approximately 60 minutes before PET/CT scan.
干预措施: 68Ga-DOTATATE (Drug)
68Ga-DOTATATE
All participants will be injected with 68Ga-DOTATATE approximately 60 minutes before PET/CT scan.
干预措施: PET/CT (Diagnostic Test)
68Ga-DOTATATE
All participants will be injected with 68Ga-DOTATATE approximately 60 minutes before PET/CT scan.
干预措施: 111In-pentetreotide OctreoScan (Diagnostic Test)
68Ga-DOTATATE
All participants will be injected with 68Ga-DOTATATE approximately 60 minutes before PET/CT scan.
干预措施: MRI (Diagnostic Test)
结局指标
主要结局
Number of lesions detected by 68GA-DOTATATE compared to conventional imaging technique
时间窗: SOT within 28 days before 68Ga-DOTATATE PET/CT scan
We want to determine if the 68Ga-DOTATATE PET/CT scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI).
次要结局
- Frequency and severity of Adverse Events(4 days)
研究者
Ebrahim Delpassand
President
Radio Isotope Therapy of America