MRI and Biomarkers for Lung Nodules Detected During Lung Cancer Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lung MRI, Blood Draw.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Study Evaluating the Feasibility of Novel MRI Sequences and Blood-Based Biomarkers for Discriminating Nodules Found During Lung Cancer Screening
Overview
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 test Lung MRI
MRI of the lung - Diagnostic test Blood Draw
Blood Draw
Primary outcome measures
- Accrual and Retention Rate [Time frame: 3 years]
Secondary outcome measures (5)
- Concordance of Size of Nodules [Time frame: 3 Years]
- Concordance of Nodule Features: Presence of Calcifications [Time frame: 3 years]
- Concordance of Nodule Features: Presence of Fat [Time frame: 3 years]
- Concordance of Nodule Features: Presence of Spiculations [Time frame: 3 years]
- Concordance of Nodule Features: Solid, Part Solid, Non-Solid [Time frame: 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Cedars-Sinai Medical Center — Los Angeles
Identifiers
NCT: NCT05699213 · STUDY00002249