MRI and Biomarkers for Lung Nodules Detected During Lung Cancer Screening

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT05699213
• Lead Sponsor: Cedars-Sinai Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2023-01-22
• Study First Posted: 2023-01-26
• Study Start: 2023-06-27
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Primary Completion: 2026-06-27
• Study Completion: 2026-08-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accrual and Retention Rate	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.

Secondary Outcome Measures

Name	Time	Method
Concordance of Nodule Features: Presence of Calcifications	3 years	The secondary objective of this study is to evaluate the concordance of imaging features of nodules on LDCT versus MRI in a screening population. Concordance for the presence of calcifications will be analyzed using McNemar's test, sensitivity and specificity.
Concordance of Size of Nodules	3 Years	The secondary objective of this study is to evaluate the concordance of imaging features of nodules on LDCT versus MRI in a screening population. Concordance of the size of nodules on LDCT versus MRI will be analyzed using Bland Altman and linear regression.
Concordance of Nodule Features: Presence of Fat	3 years	The secondary objective of this study is to evaluate the concordance of imaging features of nodules on LDCT versus MRI in a screening population. Concordance for the presence of fat will be analyzed using McNemar's test, sensitivity and specificity.
Concordance of Nodule Features: Presence of Spiculations	3 years	The secondary objective of this study is to evaluate the concordance of imaging features of nodules on LDCT versus MRI in a screening population. Concordance for the presence of spiculations will be analyzed using McNemar's test, sensitivity and specificity.
Concordance of Nodule Features: Solid, Part Solid, Non-Solid	3 years	The secondary objective of this study is to evaluate the concordance of imaging features of nodules on LDCT versus MRI in a screening population. Concordance for whether the nodule is solid, part solid, or non-solid will be analyzed using McNemar's test, sensitivity and specificity.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States