MRI and Biomarkers for Lung Nodules Detected During Lung Cancer Screening

NCT ID: NCT05699213

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-27

Study Completion Date

2026-08-27

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Lung MRI

MRI of the lung

Intervention Type DIAGNOSTIC_TEST

Blood Draw

Blood Draw

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sara Ghandehari

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sara Ghandehari, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Weijia Chua, MD

Role: CONTACT

310-423-1838

Facility Contacts

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Weijia Chua, M.D.

Role: primary

Other Identifiers

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STUDY00002249

Identifier Type: -

Identifier Source: org_study_id

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