MRI and Biomarkers for Lung Nodules Detected During Lung Cancer Screening

Study Overview
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Diagnostic Test: Lung MRI
* Diagnostic Test: Blood Draw


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Lung MRI|MRI of the lung|
|Diagnostic Test: Blood Draw|Blood Draw|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |