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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01799135
Recruitment Status : Active, not recruiting
First Posted : February 26, 2013
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Raymond H. Mak, Dana-Farber Cancer Institute

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

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



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.




Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799135


Locations
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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
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Principal Investigator: Raymond Mak, MD Dana-Farer Cancer Institute
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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    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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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