MRI and Biomarkers for Lung Nodules Detected During Lung Cancer Screening

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05699213
• Other study ID #: STUDY00002249
• Status: Recruiting
• Start date: June 27, 2023
• Est. completion date: August 27, 2026

Study information

• Verified date: August 2023
• Source: Cedars-Sinai Medical Center
• Contact: Weijia Chua, MD
• Phone: 310-423-1838
• Email: weijia.chua[@]cshs.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 27, 2026
• Est. primary completion date: June 27, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Diagnostic Test:
• Lung MRI
MRI of the lung
• Blood Draw
Blood Draw

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Outcomes	The exploratory objectives of this study are to generate preliminary data in support of larger studies in a lung cancer screening population looking at: 1) the use of genetic biomarkers and 2) the use of novel MRI acquisition parameters and radiomics	3 years
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.	3 years
Secondary	Concordance of Size of Nodules	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.	3 Years
Secondary	Concordance of Nodule Features: Presence of Calcifications	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.	3 years
Secondary	Concordance of Nodule Features: Presence of Fat	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.	3 years
Secondary	Concordance of Nodule Features: Presence of Spiculations	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.	3 years
Secondary	Concordance of Nodule Features: Solid, Part Solid, Non-Solid	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.	3 years