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

NCT ID: NCT02722395

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-02-01

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

Conditions

Primary Liver Cancer; Metastatic Liver Cancer From Any Cancer Site

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Single arm cohort study

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Czito

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00071159

Identifier Type: -

Identifier Source: org_study_id