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Trial Title: MRI and Biomarkers for Lung Nodules Detected During Lung Cancer Screening

NCT ID: NCT05699213

Condition: Lung Cancer

Conditions: Official terms:
Lung Neoplasms

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Lung MRI
Description: MRI of the lung

Intervention type: Diagnostic Test
Intervention name: Blood Draw
Description: Blood Draw

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.

Criteria for eligibility:

Study pop:
The primary subject population will be patients who qualify for lung cancer screening based on United States Preventive Services Taskforce (USPSTF) guidelines: Age 50-80 with 20 or greater pack-year smoking history who continue to smoke or have quit within the past 15 years without sign or symptoms of lung cancer. The secondary subject population will be patients who are at increased risk of lung cancer based on National Comprehensive Cancer Network (NCCN) guidelines, but do not meet the USPSTF guidelines

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 50 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Cedars-Sinai Medical Center

Address:
City: Los Angeles
Zip: 90048
Country: United States

Status: Recruiting

Contact:
Last name: Weijia Chua, M.D.

Start date: June 27, 2023

Completion date: August 27, 2026

Lead sponsor:
Agency: Cedars-Sinai Medical Center
Agency class: Other

Source: Cedars-Sinai Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05699213

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