NCT05785663已完成不适用
AminoMedixTM for Radiation Kidney Protection During Peptide-Receptor Radionuclide Therapy (PRRT): Phase I, II Clinical Trial
Excel Diagnostics and Nuclear Oncology Center0 个研究点目标入组 28 人开始时间: 2014年8月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- Evaluation of kidney radiation dosimetry in subjects with and without AminoMedix™ using 68Ga-DOTATATE PET/CT imaging as a surrogate marker for 177Lu-DOTATATE™
研究概览
简要总结
This is a phase I, and II, single-center, open-label clinical trial to evaluate the safety and preliminary efficacy information of AminoMedix™ in protecting kidneys from radiation-induced toxicity during Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE in patients with neuroendocrine cancers.
Aims of the study:
- Evaluation of the safety of AminoMedix ™ infusion.
- Evaluation of kidney radiation dosimetry with and without AminoMedix™ using 68Ga-DOTATATE PET/CT imaging as a surrogate marker for 177Lu-DOTATATE.
- Evaluation of the safety and calculation of kidney and tumor radiation dosimetry after AminoMedix™ infusion with low dose 177Lu-DOTATATE in patients with neuroendocrine cancers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with neuroendocrine tumors are eligible to be recruited in this project.
- •Signed informed consent.
- •Patients of either gender, age 18 years or older.
- •Na+, K+, Cl,: within normal range
- •eGFR: > 50 mL/min
- •Serum creatinine: <150μmol/L. Serum creatinine: within normal range or <120μmol/L for patients aged 60 years or older.
- •Negative pregnancy test (urine test or beta-HCG) in women capable of child-bearing.
排除标准
- •Known hypersensitivity to Amifostine, Lysine, Arginine, DOTA, 68Gallium, to DOTATATE 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.
- •Pre-existing cardiovascular or cerebrovascular conditions such as congestive heart failure, ischemic heart disease, arrhythmias, or a history of stroke or transient ischemic attacks.
- •Uncontrolled kidney disease and patients who are under dialysis.
- •Current treatment with potentially nephrotoxic drugs such as aminoglycosides.
- •Less than 24 hours of withdrawal of antihypertensive medications or uncontrolled hypertension, and diabetes at the time of the study.
- •Patients under total or partial parenteral nutrition.
结局指标
主要结局
Evaluation of kidney radiation dosimetry in subjects with and without AminoMedix™ using 68Ga-DOTATATE PET/CT imaging as a surrogate marker for 177Lu-DOTATATE™
时间窗: 24 hours to 3 weeks between two dosimetry
Dosimetry results of 68Ga-DOTATATE in subjects, with and without AminoMedixTM will be compared. Each Subject will be imaged with and without AminoMedixTM 24 hours to 3 weeks apart and the reduction ratio will be calculated
次要结局
- Frequency and Severity of Adverse Events after AminoMedix™ infusion(Subjects will be followed for two weeks following administration of AminoMedix™)
研究者
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