Feasibility Study of Enhanced MRI for Early Stage Non Small Cell Lung Cancer (NSCLC)

• ClinicalTrials.gov Identifier: NCT01799135
• Recruitment Status: Active, not recruiting
• First Posted: February 26, 2013
• Last Update Posted: July 21, 2020
• Sponsor: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Raymond H. Mak, Dana-Farber Cancer Institute

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Non Small Cell Lung Cancer	Other: DCE-MRI scan; Radiation: Stereotactic Body Radiation Therapy; Other: 4D-CT scan	Early Phase 1

Detailed Description:

If you agree to participate in this research study you will be asked to undergo some screening tests or procedures to find out if you can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures include: a medical history, performance status, physical exam, assessment of tumor, assessment of breathing function and blood tests. We will also confirm that you have no contraindications to MRIs. If these tests confirm that you are eligible to participate in the research study, you will begin the study scans. If you do not meet the eligibility criteria you will not be able to participate in this research study.

If you qualify for this research study, you will come for the first study visit that will last about one and a half hours. We will use the first 30 minutes to make sure you can undergo a MRI scan (MRI screening).

Before the MRI scan, we will explain how we want you to breathe during the scan. You will breathe in small and regular breaths for one part of the exam. In another part of the exam, you will hold your breath as much as possible and breathe in between breath-holds.

An MRI contrast agent called gadolinium will be injected into a vein in your arm through an intravenous (IV) line. A contrast agent is a dye that is injected into the body to allow for better visualization (images) during an MRI exam.

You will be aked to lie down on your back on a platform that can slide into the scanner. The scan will last 60 minutes. You will hear a loud knocking or hammering noise while the MRI is taking pictures, but the process itself will be painless. You will be given disposable earplugs to help make the noise less noticeable.

During the procedure, you will be able to talk to the MRI technician through an intercom. If you feel too uncomfortable to continue the scan for any reason, the procedure will be immediately stopped and you will be removed from the MRI scanner.

You will then undergo a standard treatment planning session for SBRT. This will include a standard 4D-CT scan and a standard planning CT scan. As part of the standard planning CT scan, an intravenous (IV, through a vein) line will be placed, and you will receive an injection of IV contrast. The planning process will be conducted exactly as it would if you were not participating in this research study; it is not experimental in any way.

One to two weeks later, you will start standard SBRT treatment for your early stage non-small cell lung cancer. This treatment will be delivered exactly as it would if you were not participating in this research study; it is not experimental in any way.

After the first treatment, you will undergo your second study DCE-MRI, which is identical to the initial DCE-MRI scan as described above.

You will then have two more study visits for the post-treatment research scans. The first visit will occur 1-2 weeks after completion of SBRT. It will involve a 30-minute routine clinic visit with your radiation oncologist to assess your recovery from treatment, and then you will undergo your third study DCE-MRI, which is identical to the DCE-MRI scans described above.

You will then undergo the fourth (final) study DCE-MRI scan 3-4 months after completion of SBRT. This scan will be identical to the three previous DCE-MRI scans. At this visit, you will also have a repeat 4D-CT scan which is study related. You will also have a routine clinic visit with your radiation oncologist at this time. You will then undergo the standard post-treatment re-evaluation imaging including a repeat PET/CT and a pulmonary function test.

Once you have completed the DCE-MRI scans, no further study follow-up will be necessary. However, you will continue with routine follow-up with your radiation oncologist as part of standard care. You will be in this research study for approximately four months.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Feasibility Study of the Utility of Pulmonary Dynamic Contrast Enhanced MRI for Assessment of Tumor Response and Lung Injury and for Treatment Planning for Stereotactic Body Radiation Therapy for Early Stage Non-Small Cell Lung Cancer
• Study Start Date: April 2012
• Actual Primary Completion Date: January 2019
• Estimated Study Completion Date: December 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental Arm; DCE-MRI scan (4 scans total); Stereotactic Body Radiation Therapy; 4D-CT scan	Other: DCE-MRI scan; Radiation: Stereotactic Body Radiation Therapy; Other: 4D-CT scan

Outcome Measures

Primary Outcome Measures :

1. Change in tumor perfusion from baseline 1-2 days after the first SBRT treatment [ Time Frame: 2 days ]

   Change in tumor perfusion is defined as a 20% change in tumor perfusion from baseline scan.

   Time to peak perfusion signal and enhancement ratio (defined as post- to pre-contrast perfusion signal) at the time of maximal parenchymal enhancement (TMPE) will be measured on each DCE-MRI scan. Pharmacokinetic parameters, including the volume transfer constant (Ktrans), the fractional volume of extravascular extracellular space of the target tissue (ve), and the rate constant (kep), will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.

2. Change in tumor perfusion from baseline 1-2 weels after completion of SBRT treatment [ Time Frame: 2 weeks ]

   Change in tumor perfusion is defined as a 20% change in tumor perfusion from baseline scan.

   Time to peak perfusion signal and enhancement ratio (defined as post- to pre-contrast perfusion signal) at the time of maximal parenchymal enhancement (TMPE) will be measured on each DCE-MRI scan. Pharmacokinetic parameters, including the volume transfer constant (Ktrans), the fractional volume of extravascular extracellular space of the target tissue (ve), and the rate constant (kep), will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.

3. Change in tumor perfusion from baseline 3-4 months after completion of SBRT treatment [ Time Frame: 4 months ]

   Change in tumor perfusion is defined as a 20% change in tumor perfusion from baseline.

   Time to peak perfusion signal and enhancement ratio (defined as post- to pre-contrast perfusion signal) at the time of maximal parenchymal enhancement (TMPE) will be measured on each DCE-MRI scan. Pharmacokinetic parameters, including the volume transfer constant (Ktrans), the fractional volume of extravascular extracellular space of the target tissue (ve), and the rate constant (kep), will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.

Secondary Outcome Measures :

1. Acute and subacute radiation-induced lung injury 3 months after completion of SBRT treatment [ Time Frame: 3 months ]

   Radiation-induced lung injury is defined as a 20% change in lung perfusion from baseline.

   Time to peak perfusion signal and enhancement ratio (defined as post- to pre-contrast perfusion signal) at the time of maximal parenchymal enhancement (TMPE) will be measured on each DCE-MRI scan. Pharmacokinetic parameters, including the volume transfer constant (Ktrans), the fractional volume of extravascular extracellular space of the target tissue (ve), and the rate constant (kep), will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.

2. Feasibility of integrating 4D-CT ventilation imaging with DCE-MRI perfusion imaging in characterizing subacute (3 months) radiation-induced lung injury after SBRT [ Time Frame: 3 months ]

   Feasibility (success) is defined as observing an analyzable change in lung perfusion of 20% from the baseline scans compared to the 3-month scans.

   Time to peak perfusion signal and enhancement ratio (defined as post- to pre-contrast perfusion signal) at the time of maximal parenchymal enhancement (TMPE) will be measured on each DCE-MRI scan. Pharmacokinetic parameters, including the volume transfer constant (Ktrans), the fractional volume of extravascular extracellular space of the target tissue (ve), and the rate constant (kep), will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02215

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Dana-Farber Cancer Institute

Investigators

• Principal Investigator: Raymond Mak, MD; Dana-Farer Cancer Institute

More Information

• Responsible Party: Raymond H. Mak, Prinicipal Investigator, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT01799135
• Other Study ID Numbers: 12-004
• First Posted: February 26, 2013
• Last Update Posted: July 21, 2020
• Last Verified: July 2020

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms