Lung Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTLung MRI
MRI of the lung
DIAGNOSTIC_TESTBlood Draw
Blood Draw
Sponsors
Cedars-Sinai Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Outcomes | 3 years | 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 |
Countries
United States
Contacts
Primary ContactWeijia Chua, MD
Outcome results
None listed