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Magnetic Resonance Imaging (MRI) Solely For Liver Stereotactic Body Radiation Therapy (SBRT)

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. Identifier: NCT02722395
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : April 6, 2017
Information provided by (Responsible Party):
Duke University

Brief Summary:
This study is a research and development initiative established to explore the use of magnetic resonance imaging (MRI) as a tool for managing organ motion of the liver in cancer patients planning procedures for stereotactic body radiation therapy (SBRT).

Condition or disease
Primary Liver Cancer Metastatic Liver Cancer From Any Cancer Site

Detailed Description:
There is a potential role to systematically implement MRI to establish appropriate workflow of the implementation for tumor motion management in liver SBRT. Compared to CT, MRI has many significant advantages for radiotherapy planning, including superior tumor and soft-tissue contrast, flexible imaging orientation, freedom from radiation exposure and real-time imaging. MRI solely based liver SBRT will allow for more precise delineation of target volume, less uncertainties in treatment planning, better motion management, and potentially better treatment outcome

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance Imaging (MRI) Solely For Liver Stereotactic Body Radiation Therapy (SBRT)
Study Start Date : August 2016
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Single arm cohort study

Primary Outcome Measures :
  1. Measure average motion trajectories [ Time Frame: During MRI approx 1 hour ]
  2. Image quality, as measured by image rating [ Time Frame: During MRI approx 1 hour ]
    Image quality will be measured on a scale of 1 to 5, 1 being the best.

  3. Image quality, as measured by tumor volume [ Time Frame: During MRI approx 1 hour ]
  4. Image quality, as measured by tumor-to-live contrast to noise ratio [ Time Frame: During MRI approx 1 hour ]
  5. Planning target volume (PTV) [ Time Frame: During MRI approx 1 hour ]
    PTV is defined as PTV=internal target volume (ITV) + safety margin (M)

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with stage I, II, III primary liver cancer Patients with metastatic liver cancer from any cancer site

Inclusion Criteria:

  • Age ≥ 21
  • Patients with primary stage I, II, III liver cancer or metastatic tumor in the liver from any cancer site
  • Signed, specific informed consent prior to study entry
  • Women of child bearing potential must have a negative serum pregnancy test

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.
  • Pregnant or breast-feeding women are excluded.
  • Subjects who have difficulty lying flat on their back for extended periods of time

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 identifier (NCT number): NCT02722395

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
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Principal Investigator: Brian Czito Duke University
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Responsible Party: Duke University Identifier: NCT02722395    
Other Study ID Numbers: Pro00071159
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases