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MRI and Biomarkers for Lung Nodules Detected During Lung Cancer Screening

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05699213
Collaborator
(none)
30
Enrollment
36
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Lung MRI
  • Diagnostic Test: Blood Draw

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Pilot Study Evaluating the Feasibility of Novel MRI Sequences and Blood-Based Biomarkers for Discriminating Nodules Found During Lung Cancer Screening
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2026
Anticipated Study Completion Date :
Feb 1, 2026

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Sara Ghandehari, MD, Cedars-Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sara Ghandehari, Associate Professor, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT05699213
Other Study ID Numbers:
  • STUDY00002249
First Posted:
Jan 26, 2023
Last Update Posted:
Jan 26, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Lung Neoplasms

Study Results

No Results Posted as of Jan 26, 2023