Exploratory study on clinical applications of photon counting detector CT

未提供0 个研究点目标入组 360 人开始时间: 待定最近更新: 2024年4月24日

试验速览

阶段: 不适用
状态: 招募中
入组人数: 360
主要终点: -

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Non-randomized Controlled Trial
干预模型: Single Assignment
主要目的: Diagnostic Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 20age 0month 0week old over 至 No limit（—）
性别: All

入选标准

•Voluntary written consent to participate in this study has been obtained.
•Aged 20 years or older on the date of informed consent.
•ECOG Performance Status is
•Expected survival of 12 weeks or more.
•Has been diagnosed with or suspected of having a solid tumor.
•No history of hypersensitivity to iodinated contrast media and no contraindications to the use of iodinated contrast media
•Renal function within 30 days before enrollment: eGFR 45 or higher (no CKD or CKD stage 1, 2, or 3a). If multiple renal function tests are available, the result of the renal test which is closest to the date of the protocol test will be used.
•Those who required a contrast-enhanced CT examination at our hospital (National Cancer Center Hospital East)
•Continuing examination and treatment for definitive diagnosis etc. are scheduled at our hospital (National Cancer Center Hospital East).
•Cohort 2, standard dose group (Criteria 1-8 are common to Cohort 1 and Cohort 2 standard groups, and only criteria 9 is added in Cohort
•If consent is obtained, simultaneous enrollment is permitted in both Cohort 1 and Cohort 2 standard groups.)
•Voluntary written consent to participate in this study has been obtained.
•Aged 20 years or older on the date of informed consent.
•ECOG Performance Status is
•Expected survival of 12 weeks or more.
•Has been diagnosed with or suspected of having a solid tumor.
•No history of hypersensitivity to iodinated contrast media and no contraindications to the use of iodinated contrast media
•Renal function within 30 days before enrollment: eGFR 45 or higher (no CKD or CKD stage 1, 2, or 3a)
•Those who required a contrast-enhanced CT examination at our hospital (National Cancer Center Hospital East)
•Cohort 2, reduced dose group
•Voluntary written consent to participate in this study has been obtained.
•Aged 20 years or older on the date of informed consent.
•ECOG Performance Status is
•Expected survival of 12 weeks or more.
•Has been diagnosed with or suspected of having a solid tumor.
•No history of hypersensitivity to iodinated contrast media and no contraindications to the use of iodinated contrast media
•Renal function within 30 days before enrollment: eGFR ranging from 30 or higher to 44 (CKD stage 3b)
•Those who required a contrast-enhanced CT examination at our hospital (National Cancer Center Hospital East)
•Scheduled reevaluation of renal function test basically within the 14 days (maximum 28 days) after the protocol test.

排除标准

•Cohort 1 and Cohort 2 (standard dose and reduced dose groups)
•a person with a cardiac pacemaker
•a woman with pregnant or breastfeeding.
•other serious acute or chronic medically significant conditions
•When the principal investigator or co-investigator determines that enrollment in this study is inappropriate.
•Cohort 2, standard dose and reduced dose groups
•Not scheduled reevaluation of renal function test within the 30 days after the protocol test.

结局指标

主要结局

Cohort 1 : Specificity Cohort 2 : Image quality score

次要结局

Image quality score
Signal-to-noise ratio
Contrast noise ratio
Renal function tests and change ratio of the renal function test

研究者

发起方

未提供

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