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临床试验/NCT03528200
NCT03528200已完成不适用

Pilot Study of IV Dyna CT and CBV Imaging Techniques in Preparation for Vascular Embolization Procedures - DYNA EMBOLIZATION

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Correlation of CBV

研究概览

简要总结

This is a prospective pilot study evaluating the efficacy of DynaCT in direct comparison to conventional catheter angiography in demonstrating the anatomic details of the vessels supplying brain lesions. Forty patients will be recruited for this pilot study.

详细描述

There are common intracranial lesions that have increased vascularity that makes surgical resection difficult. Embolization can improve the surgical procedure by easing the resection, decreasing blood loss during surgical resection, and improving visibility of the surgical bed during resection. Conventional intra-arterial (IA) angiography is the gold standard to evaluating pathologies for embolization candidates, however the invasiveness of the procedure (with associated risks), time requirements, and resource utilization of evaluating and possibly embolization of these patients are precluding its widespread use.

Devising a test methodology that is quick, with less risk, and can accurately detect arteries that are of value in embolizing these pathologies will improve the utilization as a screening tool and will result in improved resource utilization that focuses only on those patients that require embolization. Lastly, by correlating the Dyna CBV to surgical resection quality (ease of resection, blood loss from surgical site), a non-invasive, controlled method to evaluating embolization quality can be established to aid surgeons in pre-operative planning as well as serve as a method of evaluating embolization materials designed for the blood vessels associated with brain lesions.

The DynaCT technique is a fully FDA-approved application of the Siemens imaging system and software. DynaCT is often performed during our angiographic and interventional procedures. Neurointerventionists have begun to apply this technology within their practices, and the investigators have selectively applied DynaCT for various clinical applications. However, at this point the investigators have not incorporated the technology into clinical care for patients with intracranial lesions.

Although DynaCT is an approved technology, there have been recent improvements in the software performing the 3D reconstruction. These new features will be used in this study and thus the investigators consider them to be "research scans."

Study patients will provide informed consent for the scan and the patients will not be billed for the DynaCT portion of the procedure (only the standard of care conventional angiography). The investigators have specifically chosen to image patients already undergoing conventional angiography for surgical resection in order to have a direct comparison.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • Patients scheduled to have an intracranial lesion evaluated for possible surgical resection.

排除标准

  • Patients with severe contrast allergies
  • Women who are pregnant or lactating.

结局指标

主要结局

Correlation of CBV

时间窗: One week

Correlate changes in CBV (post embolization to pre-embolization, and CBV in patients who did not get embolization) to improved surgical procedure (ease of resection, surgical blood loss).

CBV Comparison

时间窗: One week

Compare a baseline IV Dyna CBV pre-embolization and immediate post embolization CBV to assess quality of vascular embolization.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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