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Completed

NCT Number: NCT02722395

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

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).

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Key information

Conditions

Primary Liver Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Metastatic Liver Cancer From Any Cancer Site Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

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

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

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 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

Treatment and study plan

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 30, 2016
Registry last updated
Apr 6, 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.

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