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NCT Number: NCT05699213

MRI and Biomarkers for Lung Nodules Detected During Lung Cancer Screening

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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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Weijia Chua, M.D.

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung MRI

Diagnostic Test

MRI of the lung

Blood draw

Diagnostic Test

Blood Draw

Primary outcomes

  1. Accrual and Retention Rate

    Time frame: 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 outcomes

  1. Concordance of Size of Nodules

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Exploratory Outcomes

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Weijia Chua, MD

CONTACT

[email protected]

310-423-1838

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2023
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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