A Phase 0 First-in-human Clinical Trial of [203Pb]VMT-α-NET SPECT/CT for Somatostatin Receptor Imaging of Neuroendocrine Tumors
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ability of [203Pb]VMT-α-NET to identify neuroendocrine tumor lesions
研究概览
简要总结
This is a first in man study to determine if [203Pb]VMT-α-NET identifies neuroendocrine tumors with SPECT/CT. This is the first step to testing [212Pb]-based alpha radiation therapy in neuroendocrine therapy.
详细描述
The goal of this work is to use [203Pb]VMT-α-NET as the imaging agent to create a specialized patient treatment plan using [212Pb]VMT-α-NET as a first-in-human therapy for treatment resistant or refractory neuroendocrine tumors of the foregut or midgut. The first step is to test the imaging agent [203Pb]VMT-α-NET. This requires a very small dose of the drug (microdose) which is then measured by a series of images (like CT scans) over 4 days. Blood samples are also drawn that that time. It is hoped the imaging will identify the tumors so that a therapy using [212Pb]VMT-α-NET can be created.
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
- •Ability to understand and willingness to provide informed consent
- •Stated willingness to comply with all study procedures and availability for duration of study
- •Aged ≥ 18 years at the time of study drug administration
- •Pathologically confirmed (histology or cytology) well-differentiated neuroendocrine tumor (WHO Grade 1 or 2) with primary location known or believed to be midgut or foregut
- •At least 1 somatostatin receptor positive tumor site as demonstrated by PET/CT study utilizing an FDA approved PET agent within 12 months of consent
- •≥1 evaluable site of disease measuring ≥ 2.0 cm in any dimension on CT or MRI
- •Adequate performance status (ECOG of 0 or 1; or KPS of ≥70).
- •Not experiencing an uncontrolled intercurrent illness such as: infection requiring inpatient admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations, or any other condition that would limit compliance with study requirements as determined by study team members.
排除标准
- •Individuals who are pregnant or breast feeding. A pregnancy test will be administered to individuals of child-bearing potential (per institutional policies) at screening. Individuals must agree to pregnancy tests prior to each administration of a radionuclidic agent for this study.
- •Individuals of reproductive potential who decline to use effective contraception through the study (22 days equaling 10 half-lives).
- •Lactating individuals who decline to withhold breastfeeding their child. As the effects of [203Pb]VMT-α-NET on the infant are unknown and relatively long half-life, women may not resume breast feeding for the current child.
- •Therapeutic investigational drug within 4 weeks of C1D1
- •Patients for whom, in the opinion of their physician, a 24-hour discontinuation of somatostatin analogue therapy represents a health risk.
- •Subject's weight exceeds the limit of the imaging system.
- •Long-acting somatostatin analogue treatment ≤ 20 days of C1D1
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to [90Y]DOTA-tyr3-Octreotide, Octreoscan®, or [68Ga]Octreotide.
研究组 & 干预措施
[203Pb]VMT-α-NET SPECT/CT
injection of [203Pb]VMT-α-NET with serialized imaging and dosimetry measurements
干预措施: [203Pb]VMT-α-NET (Drug)
[203Pb]VMT-α-NET SPECT/CT
injection of [203Pb]VMT-α-NET with serialized imaging and dosimetry measurements
干预措施: SPECT/CT (Device)
结局指标
主要结局
Ability of [203Pb]VMT-α-NET to identify neuroendocrine tumor lesions
时间窗: Study days 1 through 5
percentage of lesions detected with \[203Pb\]VMT-α-NET compared to the gold standard of NetSPOT or Ga-68 DOTATOC.
次要结局
- Measure radiation dose from [203Pb]VMT-α-NET dosimetrically(Study days 1 through 5)
- Single-time point survey(Study days 1 through 5)
研究者
Yusuf Menda
Professor and Director, Nuclear Medicine
University of Iowa