Skip to main content
OpenTrials
Completed

NCT Number: NCT02019199

Magnetic Resonance Imaging (MRI) in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Liver Cancer, Lung Cancer, Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To evaluate the accuracy, robustness, and efficacy of MRI for tumor motion measurement.

    Time frame: During MRI approx 1 hour

    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.).

  2. Tumor volume

    Time frame: During MRI approx 1 hour

    Free breathing/breath-hold MRI will be compared to free breathing/breath-hold CT

  3. Tumor contrast-to-noise ratio (CNR)

    Time frame: During MRI approx 1 hour

    Difference between CNR is measured by 4D-MRI and 4D-CT

  4. Tumor Motion

    Time frame: During MRI approx 1 hour

    Difference between tumor motion as measured by 2D cine-MRI vs 4D-MRI vs 4D-CT

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 24, 2013
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.