跳至主要内容
临床试验/NCT02960308
NCT02960308已完成不适用

A Pilot Study of Whole-Neck CT Perfusion With the Toshiba Aquilion ONE ViSION-320 Detector Row CT Scanner for Use in Head &Amp; Neck Tumor Patients

University of Southern California1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2016年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
1
主要终点
Number and site of each suspicious lymph node assessed by WNCTP

研究概览

简要总结

This pilot clinical trial studies how well whole-neck computed tomography perfusion scans work in imaging patients with head and neck tumors. Diagnostic imaging procedures, such as whole-neck computed tomography perfusions scans, may provide more information about the blood supply to head and neck tumors which may help doctors plan better treatment.

详细描述

PRIMARY OBJECTIVES:

I. To assess the difference in whole-neck computed tomography perfusion (WNCTP) parameters (blood volume [BV], blood flow [BF], capillary permeability [CP] and mean transit time [MTT]) between head and neck tumor masses (benign or malignant) and adjacent normal skeletal muscle within the same patient.

II. To assess whether the difference in WNCTP parameters between tumor masses and adjacent normal skeletal muscle is different between patients with benign tumor versus (vs.) malignant tumor.

III. To assess the correlation in WNCTP parameters between tumor masses and adjacent normal skeletal muscle.

IV. Determine if more suspicious cervical lymph nodes will be seen using the whole-neck coverage employed in WNCTP compared to the limited coverage of traditional neck CTP.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Confirmed or suspected head and neck tumor (benign or malignant)
  • Scheduled for contrast CT (standard of care)
  • No known allergies to contrast material

排除标准

  • Known allergies to contrast material
  • Pregnant or nursing

结局指标

主要结局

Number and site of each suspicious lymph node assessed by WNCTP

时间窗: Day 1

Will be compared to traditional neck CTP. Within each patient, the number and sites of each suspicious lymph node will be recorded for the whole-neck imaging area. A 95% confidence interval for the proportion of patients whose status (lymph node negative \[LN-\] versus lymph node positive \[LN+\]) was changed based on the WNCTP image compared to standard of care will be constructed.

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 (1)

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