Magnetic Resonance Imaging (MRI) in Motion

Magnetic Resonance Imaging ( MRI) for Radiation Therapy Treatment Planning Evaluation of Lung, Liver and Pancreatic Motion.

This study is a research initiative established to explore the use of magnetic resonance imaging (MRI) as a tool for detecting organ motion as it pertains to planning radiation therapy.

Study Overview

• Status: Completed
• Conditions: Liver Cancer, Lung Cancer, Pancreatic Cancer

Detailed Description

The goal with radiation therapy is to treat the defined tumor and spare the surrounding normal tissue from receiving dose above specified tolerance doses. There is evidence of improved local control and survival with higher doses of radiation, however, at the same time there is the need to spare normal tissues from higher doses of radiation. Technologies that allow the delivery of an increased radiation dose to the tumor while sparing normal tissue have the potential of improving the therapeutic ratio. However, the development of these technologies has been hampered by organ respiratory motion particularly in the case of the lungs and liver. Inadequate radiation coverage of a tumor secondary to organ motion can lead to delivering a lower dose to a portion of the tumor. Making the field of radiation larger to account for organ motion results in unnecessary radiation dose to surrounding healthy tissues. It is therefore desirable to document the extent of motion of the organ in question prior to carrying out the radiation treatment planning. The organ motion impacts directly on the radiation dose distribution in the treatment volume.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults males or females with primary or secondary cancer tumors of the lung, liver or pancreas

Description

Inclusion Criteria:

• Age ≥ 21
• Patients with primary or metastatic tumors in the lungs, liver, or pancreas
• Patients undergoing a planning CT scan in the Department of Radiation Oncology with tumor motion assessment - planning 4D-CT ordered by the treating Radiation Oncologist
• Signed, specific informed consent prior to study entry

Exclusion Criteria:

• Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel, etc
• Pregnant or breast-feeding women
• Subjects who have difficulty lying flat on their back for extended periods of time

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the accuracy, robustness, and efficacy of MRI for tumor motion measurement.	MRI and CT ( all subjects will have a standard of care CT scan) data in DICOM format will be collected for analysis using commercial or customized - developed software. Image quality will be assessed based on signal-to-noise (SNR), contrast-to-noise ratio (CNR), and the presence of image artifacts. Data to be computed include, but are not limited to, tumor volumes (gross tumor volume, internal target volume, planning target volume, etc.), tumor motion parameters (range, trajectory, frequency, variation, probability distribution, etc.), and treatment plan parameters (target coverage, dose-volume-histogram, etc.).	During MRI approx 1 hour
Tumor volume	Free breathing/breath-hold MRI will be compared to free breathing/breath-hold CT	During MRI approx 1 hour
Tumor contrast-to-noise ratio (CNR)	Difference between CNR is measured by 4D-MRI and 4D-CT	During MRI approx 1 hour
Tumor Motion	Difference between tumor motion as measured by 2D cine-MRI vs 4D-MRI vs 4D-CT	During MRI approx 1 hour

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Brian Czito, MD, Duke University

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: December 18, 2013
• First Submitted That Met QC Criteria: December 18, 2013
• First Posted (Estimate): December 24, 2013

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 7, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pancreatic Diseases; Lung Neoplasms; Pancreatic Neoplasms
• Other Study ID Numbers: Pro00032595