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RecruitingObservational

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

NCT ID: NCT05699213Sponsor: Cedars-Sinai Medical CenterLast updated: 2023-08-30

Summary

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.

Arms & interventions

  • Diagnostic TestLung MRI

    MRI of the lung

  • Diagnostic TestBlood Draw

    Blood Draw

Outcome measures

Primary

  • Accrual and Retention Rate

    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.

    Time frame: 3 years

Secondary

  • Concordance of Size of Nodules

    Time frame: 3 Years

  • Concordance of Nodule Features: Presence of Calcifications

    Time frame: 3 years

  • Concordance of Nodule Features: Presence of Fat

    Time frame: 3 years

  • Concordance of Nodule Features: Presence of Spiculations

    Time frame: 3 years

  • Concordance of Nodule Features: Solid, Part Solid, Non-Solid

    Time frame: 3 years

Eligibility criteria

Sex: AllAge: 50 Years and olderHealthy volunteers: Yes
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study locations (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Recruiting
Weijia Chua, M.D. · Contact
MRI and Biomarkers for Lung Nodules Detected During Lung Cancer Screening | Cancerify