Feasibility Study of Enhanced MRI for Early Stage Non Small Cell Lung Cancer (NSCLC)
This is a pilot study. A pilot study is done with a small number of participants to see if a technique works before using it in a larger research study. This pilot study is evaluating a special kind of MRI scan of the lungs called dynamic contrast enhanced MRI (DCE-MRI). DCE-MRI can demonstrate how much blood flows through the tumor and lungs and tell us how active the tumor is, as well as how functional the lungs are. As part of this scan, participants will receive an intravenous (into the blood via puncture of a vein) injection of gadolinium contrast, a dye that helps us see the tumor and lung tissue more clearly. Gadolinium is approved by the FDA and is routinely used for MRI. The goal of the study is to determine whether DCE-MRI can provide images of the response of the tumor and the normal lung tissue to SBRT and to potentially hep improve treatment-planning methods for patients treated with SBRT in the future. We will also study how the final DCE-MRI scan compares with another form of imaging, called 4-dimensional computed tomography (4D-CT), that looks at the breathing capacity of the lungs. Although we are researching the usefulness of DCE-MRI in early stage non-small cell lung cancer treated with SBRT in this study, DCE-MRI with the dye injection is not an experimental technology and is routinely used in the clinic for other indications. The 4D-CT scan is also not experimental and is used for radiation planning and imaging of the lungs. The SBRT you will receive will be standard treatment and will not be affected by your participation in this study or by these DCE-MRI scans. That means that the findings on the scan will not be used to alter your planned treatment in any way. Additionally, participants will undergo the routine work-up prior to SBRT and surveillance studies after treatment is complete.
Checked against the public recordLast updated Oct 12, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Dana-Farber Cancer Institute
- Interventions being studied
- Other: DCE-MRI scan; Radiation: Stereotactic Body Radiation Therapy; Other: 4D-CT scan
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Histologically confirmed non-small cell lung cancer * Tumor between 1 cm and 6 cm * No evidence of nodal involvement or distant metastases * Deemed to be a candidate for stereotactic body radiation therapy for NSCLC * Able to lie still during DCE-MRI (up to 60 minutes) * Adequate renal function to tolerate intravenous gadolinium contrast injection Exclusion Criteria: * Prior thoracic radiotherapy or surgery * Implanted pacemaker or cardiac defibrillator * Contraindications to undergoing MRI * Uncontrolled intercurrent illness * Pregnant or breastfeeding
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Brigham and Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 12, 2021. Always confirm current availability with the study team.