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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


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information

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


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.


Inclusion Criteria:



- Histologically confirmed non-small cell lung cancer

- Tumor between 1.5 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Feasibility of utilizing pulmonary DCE-MRI to assess for changes in tumor perfusion during SBRT (1-2 days after the first treatment) and post-treatment (at 1-2 weeks and at 3-4 months after SBRT treatment) for stage I NSCLC

Outcome Description:

Feasibility (success) is defined as successfully detecting an analyzable change (20% change in tumor perfusion).

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Raymond Mak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farer Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

12-004

NCT ID:

NCT01799135

Start Date:

April 2012

Completion Date:

Related Keywords:

  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115