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).

Study Overview

• Status: Completed
• Conditions: 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

• Study Type: Observational
• Enrollment (Actual): 5

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

Patients with stage I, II, III primary liver cancer Patients with metastatic liver cancer from any cancer site

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Single arm cohort study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure average motion trajectories		During MRI approx 1 hour
Image quality, as measured by image rating	Image quality will be measured on a scale of 1 to 5, 1 being the best.	During MRI approx 1 hour
Image quality, as measured by tumor volume		During MRI approx 1 hour
Image quality, as measured by tumor-to-live contrast to noise ratio		During MRI approx 1 hour
Planning target volume (PTV)	PTV is defined as PTV=internal target volume (ITV) + safety margin (M)	During MRI approx 1 hour

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: March 14, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimate): March 30, 2016

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: Pro00071159

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO