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

Completed

• Conditions: Metastatic Liver Cancer From Any Cancer Site; Primary Liver Cancer

• Registration Number: NCT02722395
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-30
• Study Start: 2016-08
• Primary Completion: 2017-02-01
• Study Completion: 2017-02-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States