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临床试验/NCT05386043
NCT05386043招募中不适用

Registering Genomics and Imaging of Tumors (ReGIT)

Indiana University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年7月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Classification sensitivity

研究概览

简要总结

This study is investigating how brain tumors might mutate over time, and whether new brain imaging tools like MRI and PET can predict these mutations.

详细描述

This study is investigating how brain tumors might mutate over time, and whether new brain imaging tools like MRI and PET can predict these mutations. Subjects who are radiologically diagnosed with gliomas and are expected to undergo a tumor biopsy will be enrolled in the study. Subjects will complete two visits and will then undergo a follow-up period. At the baseline visit, subjects will under go a pregnancy test (if applicable), two PET-CT scans using different radioactive tracers, an MRI scan, and blood draws. At the biopsy visit, the subject will undergo an MRI scan as part of their standard of care and at least biopsy samples will be collected for research purposes using stereotactic core biopsy. The study team will take pictures of the locations of tumor samples as they are removed during surgery. The samples then get studied for genetic mutations, and the study team will look at the parts of the image the samples came from to see if they could have been predicted. Follow-up MRIs and potentially other radiology scans will be completed as part of subjects' regular care on a schedule determined by their healthcare provider at the facility ordered by their physician. The study team will follow subjects' care and collect the information from their regularly scheduled treatments and brain scans after their biopsy.

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Baseline Imaging and Biopsy

Subjects will receive a PET-CT with the radiopharmaceuticals FET and O-15 Water (under RDRC approval for basic research) prior to their standard of care neurosurgery via stereotactic core biopsy. Research samples will be collected for analysis intraoperatively.

干预措施: O-15 Radioisotope (Drug)

Baseline Imaging and Biopsy

Subjects will receive a PET-CT with the radiopharmaceuticals FET and O-15 Water (under RDRC approval for basic research) prior to their standard of care neurosurgery via stereotactic core biopsy. Research samples will be collected for analysis intraoperatively.

干预措施: FET F-18 (Drug)

Baseline Imaging and Biopsy

Subjects will receive a PET-CT with the radiopharmaceuticals FET and O-15 Water (under RDRC approval for basic research) prior to their standard of care neurosurgery via stereotactic core biopsy. Research samples will be collected for analysis intraoperatively.

干预措施: CT scan (Procedure)

Baseline Imaging and Biopsy

Subjects will receive a PET-CT with the radiopharmaceuticals FET and O-15 Water (under RDRC approval for basic research) prior to their standard of care neurosurgery via stereotactic core biopsy. Research samples will be collected for analysis intraoperatively.

干预措施: MRI with gadolinium-based contrast (Procedure)

Baseline Imaging and Biopsy

Subjects will receive a PET-CT with the radiopharmaceuticals FET and O-15 Water (under RDRC approval for basic research) prior to their standard of care neurosurgery via stereotactic core biopsy. Research samples will be collected for analysis intraoperatively.

干预措施: Biopsy Collection (Procedure)

结局指标

主要结局

Classification sensitivity

时间窗: Through study completion, an average of 1 year.

Statistical evaluation of the area under the ROC curve. 3.1.1 SMM classification sensitivity to \>80% 3.1.2 Reduce computation time by a factor of 10, and maintain accuracy (\>.95)

Multivariate analysis

时间窗: 2032

Statistically determine if MRI, and 15O-H2O and FET-PET (if available) independently predict multiscale properties and together improve classification accuracy and sensitivity for SMM compared to 5 baseline MR sequences

Survival

时间窗: 2032

Statistically determine if SMM classifications using MRI, and 15O-H2O and FET-PET (if available) can predict progression-free survival (PFS) and overall survival (OS), and individual voxel responses to chemotherapy and radiation therapy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jason Parker

Associate Professor, Department of Radiology and Imaging Sciences

Indiana University

研究点 (1)

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