Clinical trial NCT05699213: MRI and Biomarkers for Lung Nodules Detected During Lung Cancer Screening
Official title: A Pilot Study Evaluating the Feasibility of Novel MRI Sequences and Blood-Based Biomarkers for Discriminating Nodules Found During Lung Cancer Screening
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


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

Primary outcomes:
measure: Accrual and Retention Rate
timeFrame: 3 years
Secondary outcomes:
measure: Concordance of Size of Nodules
timeFrame: 3 Years
measure: Concordance of Nodule Features: Presence of Calcifications
timeFrame: 3 years
measure: Concordance of Nodule Features: Presence of Fat
timeFrame: 3 years
measure: Concordance of Nodule Features: Presence of Spiculations
timeFrame: 3 years
measure: Concordance of Nodule Features: Solid, Part Solid, Non-Solid
timeFrame: 3 years
Other outcomes:
measure: Exploratory Outcomes
timeFrame: 3 years
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai
name: Sara Ghandehari, MD
role: PRINCIPAL_INVESTIGATOR
References: