Clinical trial · Observational
MRI and Biomarkers for Lung Nodules Detected During Lung Cancer Screening
A Pilot Study Evaluating the Feasibility of Novel MRI Sequences and Blood-Based Biomarkers for Discriminating Nodules Found During Lung Cancer Screening
NCT05699213CI-TRIAL-00069194unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Draw | Diagnostic Test | — | UNRESOLVED |
| Lung MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Accrual and Retention Rate
- timeFrame
- 3 years
- description
- 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 (5)
- measure
- Concordance of Size of Nodules
- timeFrame
- 3 Years
- description
- 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.
- measure
- Concordance of Nodule Features: Presence of Calcifications
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.