Methionine PET/CT Studies In Patients With Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 503
- 试验地点
- 2
- 主要终点
- Success rate of methionine (MET) for visualizing tumors
研究概览
简要总结
The purpose of this study is to test the usefulness of imaging with radiolabeled methionine in the evaluation of children and young adults with tumor(s). Methionine is a naturally occurring essential amino acid. It is crucial for the formation of proteins. When labeled with carbon-11 (C-11), a radioactive isotope of the naturally occurring carbon-12, the distribution of methionine can be determined noninvasively using a PET (positron emission tomography) camera. C-11 methionine (MET) has been shown valuable in the monitoring of a large number of neoplasms. Since C-11 has a short half life (20 minutes), MET must be produced in a facility very close to its intended use. Thus, it is not widely available and is produced only at select institutions with access to a cyclotron and PET chemistry facility. With the new availability of short lived tracers produced by its PET chemistry unit, St. Jude Children's Research Hospital (St. Jude) is one of only a few facilities with the capabilities and interests to evaluate the utility of PET scanning in the detection of tumors, evaluation of response to therapy, and distinction of residual tumor from scar tissue in patients who have completed therapy. The investigators propose to examine the biodistribution of MET in patients with malignant solid neoplasms, with emphasis on central nervous system (CNS) tumors and sarcomas. This project introduces a new diagnostic test for the noninvasive evaluation of neoplasms in pediatric oncology. Although not the primary purpose of this proposal, the investigators anticipate that MET studies will provide useful clinical information for the management of patients with malignant neoplasms.
详细描述
The study focuses on the following objectives:
Primary objective:
- To estimate the success rate of Methionine (MET) for visualizing tumors at the time of diagnosis. The study hypothesizes that at least 70% of newly diagnosed tumors within each group will be studied and will be successfully visualized.
Secondary objective:
- To compare uptake of MET in tumors with tumor grade in patients with newly diagnosed or relapsed, and/or persistent disease. Hypothesis: high grade tumors will concentrate higher amounts of MET than lower grade tumors measured both qualitatively and semi-quantitatively.
- To examine the bio-distribution of MET in organs that do not contain tumor, in particular the lungs, heart, mediastinum, liver, spleen, pancreas, muscle, brain, and bone marrow.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants under the care of St. Jude physicians with known or suspected neoplastic disease are eligible for participation.
- •Participants will have had, or are scheduled to have clinical imaging evaluations which may include FDG PET CT, or CT, or MRI within 4 weeks of entry.
- •No limit on age or gender.
- •Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.
- •Informed consent signed by participant, parent, or guardian according to the guidelines of the institutional review board.
排除标准
- •More than 6 MET PET scans within the previous 12 months.
- •Inability or unwillingness of research participant, parent, or legal guardian/representative to give written informed consent.
- •Inclusion Criteria for Open-Access
- •All participants under the care of St. Jude physicians with known or suspected neoplastic disease are eligible for participation.
- •No limit on age or gender
- •Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.
- •Informed consent signed by participant, parent, or guardian according to the guidelines of the institutional review board.
- •Exclusion Criteria for Open-Access
- •More than 6 MET PET scans within the previous 12 months.
- •Inability or unwillingness of research participant, parent, or legal guardian/representative to give written informed consent.
研究组 & 干预措施
Participants
Participants who meet the eligibility criteria in the study will receive methionine.
干预措施: Methionine (Drug)
结局指标
主要结局
Success rate of methionine (MET) for visualizing tumors
时间窗: Baseline
To estimate the success rate of methionine (MET) for visualizing tumors at the time of diagnosis. We hypothesize that at least 70% of tumors within each group studied will be successfully visualized.
次要结局
- Bio-distribution of MET in organs(At baseline, after enrollment of the first 93 participants)
- Association of methionine uptake with tumor grade(End of study (maximum of 3 years post methionine infusion and PET scan))