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Clinical Trials/ChiCTR2100050464
ChiCTR2100050464
Active, not recruiting
Not Applicable

肿瘤靶向分子成像的应用

疑难病症诊治能力提升工程建设项目（肿瘤学）1 site in 1 countryStarted: January 1, 2021Last updated:
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Overview

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
疑难病症诊治能力提升工程建设项目（肿瘤学）
Locations
1
Primary Endpoint
最大标准摄取值
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

评价新型分子显像探针用于恶性肿瘤的早期特异性诊断与精准分期的有效性,并评价新型分子显像探针的诊断和分期效能是否优于与 18F-FDG PET/CT 常规显像。

Study Design

Study Type
诊断试验
Primary Purpose
析因分组（即根据危险因素或暴露因素分组）
Masking
未说明

Eligibility Criteria

Ages
18 to 70 (—)
Sex
All

Inclusion Criteria

  • •自愿参加并签署知情同意书；
  • •年龄>18 岁，<70 岁；
  • •常规影像学诊断恶性肿瘤病变拟行术前分期者；
  • •术前 18F-FDG PET/CT 诊断恶性肿瘤的患者；
  • •愿意并能够遵循日程访视、治疗计划和实验室检查；
  • •临床实验室普通生化检查（心、肝、肾、血常规）等指标均在正常范围或异常无临床意义。

Exclusion Criteria

  • •计划 6 个月内怀孕，或处于妊娠期或哺乳期的女性患者；
  • •对试验药物过敏、过敏体质或对多种药物过敏者；
  • •全身状况不佳，心、肺、肝、肾等重要脏器功能不能耐受手术者；
  • •注射 18F-FDG 前，空腹血糖水平超过 11.0 mmol/L;
  • •体重超过 100 kg；
  • •不能耐受双手臂上举且平卧 15-30min 者；
  • •研究者认为不宜参加本临床试验者；
  • •过去 1 个月内参加过临床试验或正在参加其他临床试验者。

Outcomes

Primary Outcomes

最大标准摄取值

平均标准摄取值

灵敏度

特异度

阳性预测值

阴性预测值

Secondary Outcomes

  • 病灶大小
  • 转移部位

Investigators

Sponsor
疑难病症诊治能力提升工程建设项目（肿瘤学）

Study Sites (1)

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