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临床试验/NCT05699213
NCT05699213招募中不适用

A Pilot Study Evaluating the Feasibility of Novel MRI Sequences and Blood-Based Biomarkers for Discriminating Nodules Found During Lung Cancer Screening

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Accrual and Retention Rate

研究概览

简要总结

The primary objective of this pilot observational study is to evaluate the accrual and retention rate of a study population from a centralized lung cancer screening program to support MRI and blood-based biomarker research for lung cancer screening.

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to read and understand informed consent
  • Male or female adults who are at high risk for lung cancer and are enrolled in the centralized lung cancer screening program: Based on USPSTF guidelines: Age 50-80 with 20 or greater pack-year smoking story who continue to smoke or quit within the past 15 years without sign or symptoms of lung cancer. Or based on National Comprehensive Cancer Network (NCCN) guidelines but do not meet the USPSTF guidelines, age 50-unlimited
  • Found to have one or more lung nodules that is 6mm or greater on screening LDCT

排除标准

  • Persons with an active diagnosis of cancer
  • Persons with active signs or symptoms of lung cancer
  • Persons with mechanically, magnetically, or electrically activated implants, such as cardiac pacemakers, neurostimulators, and infusion pumps.
  • Persons with ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged.
  • Persons who are pregnant, nursing, are implanted with intrauterine devices (IUD's) that are not MR-compatible
  • Persons unable to tolerate MRI imaging secondary to an inability to lie supine or severe claustrophobia.
  • Persons who are non-compliant with visit instructions, including inability to lie still, hold breath or follow procedure instructions

结局指标

主要结局

Accrual and Retention Rate

时间窗: 3 years

The primary outcome measure is the accrual and retention rate of a study population from a centralized lung cancer screening program to support MRI and blood-based biomarker research.

次要结局

  • Concordance of Nodule Features: Presence of Calcifications(3 years)
  • Concordance of Size of Nodules(3 Years)
  • Concordance of Nodule Features: Presence of Fat(3 years)
  • Concordance of Nodule Features: Presence of Spiculations(3 years)
  • Concordance of Nodule Features: Solid, Part Solid, Non-Solid(3 years)

研究者

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

Sara Ghandehari

Associate Professor

Cedars-Sinai Medical Center

研究点 (1)

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