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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung MRI | Diagnostic Test | MRI of the lung | ||
| Blood Draw | Diagnostic Test | Blood Draw |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weijia Chua, MD | Contact | 310-423-1838 | weijia.chua@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Sara Ghandehari, MD | Cedars-Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |