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

NCT01799135 | Terminated Results DMC

• 1 other identifier: 12-004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility Rate at 1-2 Days After the First SBRT Treatment and 1-2 Weeks and 3-4 Months After SBRT Treatment.

  Feasibility rate is defined as the number of participants with a 20% or greater change in tumor perfusion at 1-2 days, 1-2 weeks, and 3-4 months from baseline. Feasibility must be achieved at all 3 timepoints to be considered as a success. Perfusion measured using establish methods in conjunction with Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)

  Measured 1-2 days, 1-2 weeks, and 3-4 months from baseline.

Secondary Outcomes (3)

• Feasibility Rate of Using Pulmonary DCE-MRI in Characterizing Acute and Subacute Radiation-induced Lung Injury

  3 months

• Feasibility Rate of Using 4D-CT Ventilation Imaging With Pulmonary DCE-MRI in Characterizing Acute and Subacute Radiation Induced Lung Injury

  3 months

• Feasibility Rate of Using Pulmonary DCE-MRI to Identify Regions of Functional Lung for SBRT Treatment Planning

  3 months

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Stereotactic Body Radiation Therapy: either 54 Gy in 3 fractions or 50-60 Gy in 5 fraction over a span of 15 days at most. DCE-MRI was performed at four time points during therapy: at baseline prior to SBRT, 1-2 days after the first treatment fraction, 1-2 weeks after the end of the SBRT course, and 3 months after completing radiotherapy. 4D-CT scan 3 months after completing radiotherapy.

Other: DCE-MRI scan; Radiation: Stereotactic Body Radiation Therapy; Other: 4D-CT scan

Interventions

DCE-MRI scan OTHER

Experimental Arm

Stereotactic Body Radiation Therapy RADIATION

Experimental Arm

4D-CT scan OTHER

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior thoracic radiotherapy or surgery
• Implanted pacemaker or cardiac defibrillator
• Contraindications to undergoing MRI
• Uncontrolled intercurrent illness
• Pregnant or breastfeeding

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Raymond H. Mak
• Organization: Dana Farber Cancer Institute

RMAK@PARTNERS.ORG

617.632.3591

Study Officials

• Raymond Mak, MD

  Dana-Farer Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: February 26, 2013
• Study Start: November 1, 2012
• Primary Completion: January 1, 2019
• Study Completion: February 1, 2021
• Last Updated: October 12, 2021
• Results First Posted: October 12, 2021

Record last verified: 2021-09

Locations

US (2)