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Trial Title:
MRI and Biomarkers for Lung Nodules Detected During Lung Cancer Screening
NCT ID:
NCT05699213
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Lung MRI
Description:
MRI of the lung
Intervention type:
Diagnostic Test
Intervention name:
Blood Draw
Description:
Blood Draw
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
50 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Cedars-Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Weijia Chua, M.D.
Start date:
June 27, 2023
Completion date:
August 27, 2026
Lead sponsor:
Agency:
Cedars-Sinai Medical Center
Agency class:
Other
Source:
Cedars-Sinai Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05699213