NCT02348749已完成1 期
A Phase I/IIA Study of 18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- dosimetry of 18F MFBG
研究概览
简要总结
The purpose of this study is to see how a new tracer named 18F-MFBG (Meta Fluorobenzyl Guanidine) behaves in the body after injection, how it spreads to all the organs and how it is removed from the body. We will also study how long 18F-MFBG lasts in the blood after administered. In addition we want to study if 18F-MFBG can show Neuroendocrine tumors on a PET-CT or PET MR scan.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients include patients with histologically proven Neuroendocrine tumors (paraganglioma, PHEO, or well differentiated NET of the lung or GI system) or NB. Patients who have NB, the diagnosis must be in accordance with the International Criteria, i.e., either histopathology or bone marrow involvement. Patients must be ≥5 years of age and able to undergo PET scan without sedation
- •All patients must have MIBG-avid disease and evaluable disease on MIBG scan at the time of enrollment onto the protocol.
- •Performance status of ≥60 on Karnofsky scale for patients >16 years of age and >60 on Lansky scale for patients <16 years of age.
- •Cardiac, pulmonary, gastrointestinal and neurologic toxicity should all be ≤grade
- •Expansion Cohort:
- •Patients with diagnosis of NB (in accordance with the International Criteria, i.e., either histopathology or bone marrow involvement)
- •Patients must be able to undergo PET scan without sedation
- •Patients must have prior MIBG-avid disease and evaluable disease on MIBG scan at the time of enrollment onto the protocol.
- •If MIBG scan is available within 4 weeks of MFBG, with no intervening treatment, MIBG scan will not be repeated.
- •If prior MIBG scan is available >4 weeks of MFBG, MIBG scan will be done within a week (prior or after) of MFBG.
- •Performance status of ≥60 on Karnofsky scale for patients >16 years of age and >60 on Lansky scale for patients ≤16 years of age.
- •Cardiac, pulmonary, gastrointestinal and neurologic toxicity should all be ≤grade
- •Patients with positive lesion detection by 18F-MFBG may be eligible for repeat imaging scan, at the discretion of PI or study investigator(s).
排除标准
- •Major organ toxicity including cardiac, pulmonary, gastrointestinal and neurologic toxicity more than grade
- •Active serious infections not controlled by antibiotics.
- •Inability or unwillingness to undergo PET scanning
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Women who are pregnant or breastfeeding.
- •Patient has an active malignancy of metastatic potential other than the known NE tumor for the past 3 years.
- •Patients should not have received chemotherapy or radiation therapy (localized radiation therapy is allowed to non-evaluable sites) between prior 123I-MIBG scan and 18F-MFBG administration.
- •Patients requiring anesthesia, who are not already undergoing anesthesia for standard-of-care procedures.
结局指标
主要结局
dosimetry of 18F MFBG
时间窗: 1 year
in two cohorts of patients: (a) those with NB and (b) those with non-NB NE. Data will be derived from blood draws and PET/CT scans at multiple time points after injection of 18F-MFBG IV.
radioactivity
时间窗: 1 year
Multiple samples will be counted and time activity curve generated for evaluation of serum clearance. Blood samples will be centrifuged and the plasma pipetted, weighed and counted to determine the plasma time activity concentration curves (% injected dose/liter), as well as for metabolite analysis of the 18F-MFBG compound by HPLC and/or TCA methodology.
次要结局
- 18 F-MFBG imaging PET/CT to target known sites of disease(1 year)
研究者
研究点 (1)
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