An Open-Label, Multi-Center, Phase 4 Study to Evaluate the Effect of Age (Geriatric) and Renal Function on the Safety, Efficacy (Sensitivity, Specificity) and Pharmacokinetics of OctreoScan in Patients Referred for Scintigraphy of All Solid Tumors With a High Suspicion of Containing Somatostatin Receptor Positive Tissue
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Mallinckrodt
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive by biopsy with immunohistochemistry analysis
研究概览
简要总结
The objective of this study was to evaluate the effect of age (geriatric) and renal function on the safety, efficacy and pharmacokinetics of OctreoScan at the recommended clinical dose in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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
- •Males or females 18 years of age and older.
- •If female and of childbearing potential, patients must have a negative pregnancy test within 24 hours of study drug administration. In addition, all female patients of childbearing potential must agree to use a medically accepted method of contraception throughout the study.
- •If deemed necessary by the Principal Investigator, patients entering the pharmacokinetic population must be willing to be housed within the investigational facility for a minimum of 24 hours following drug administration.
- •Patients (when able) or legally authorized representatives must have the ability to understand the requirements of the study and provide written consent to participate and agree to abide by the study requirements.
- •Patients must have tumor localization by conventional imaging methods prior to enrollment (i.e., CT, MRI, US, angiogram).
- •Patients referred for scintigraphy of solid tumors with a high suspicion of containing somatostatin receptor positive tissue.
- •Patients with first-time tumors must be scheduled for a tissue biopsy. A tissue sample will be sent to the core laboratory for conventional histology and immunohistochemistry analysis.
- •Patients with recurrent tumors or progressive tumors must have previous biopsy results documented, with previous biopsy tissue obtainable for immunohistochemistry analysis.
排除标准
- •Patients receiving Sandostatin LAR < 21 days prior to dosing or Sandostatin Immediate Release (IM) < 24 hours prior to dosing.
- •Patients who have received any investigational drug within 30 days of admission into this study or plan to participate in a clinical study prior to the end of this study's monitoring period (patients on a research protocol using an approved drug are accepted).
- •Patients who are pregnant, breastfeeding or lactating.
- •Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
- •Patients scheduled to undergo any scintigraphy within 7 days prior to study participation or PET scanning within 24 hours prior to study participation.
研究组 & 干预措施
Group 1
Control, age greater than or equal to 18 with normal renal function
干预措施: Indium In-111 pentetreotide (Drug)
Group 2
Age 18 to less than 65 with mild renal impairment
干预措施: Indium In-111 pentetreotide (Drug)
Group 3
Age 18 to less than 65 with moderate to severe renal impairment
干预措施: Indium In-111 pentetreotide (Drug)
Group 4
Age 18 to less than 65 with end stage renal impairment
干预措施: Indium In-111 pentetreotide (Drug)
Group 5
Age 65 to less than 75 with mild renal impairment
干预措施: Indium In-111 pentetreotide (Drug)
Group 6
Age 65 to less than 75 with moderate to severe renal impairment
干预措施: Indium In-111 pentetreotide (Drug)
Group 7
Age 65 to less than 75 with end stage renal impairment
干预措施: Indium In-111 pentetreotide (Drug)
Group 8
Age greater than or equal to 75 with mild renal impairment
干预措施: Indium In-111 pentetreotide (Drug)
Group 9
Age greater than or equal to 75 with moderate to severe renal impairment
干预措施: Indium In-111 pentetreotide (Drug)
Group 10
Age greater than or equal to 75 with end stage renal impairment
干预措施: Indium In-111 pentetreotide (Drug)
结局指标
主要结局
Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive by biopsy with immunohistochemistry analysis
时间窗: Through 24 hours post dose
次要结局
- Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive using previously biopsied tissue for immunohistochemistry analysis(Through 24 hours post dose)