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

Primary Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722395
• Other study ID #: Pro00071159
• Status: Completed
• Phase: N/A
• First received: March 14, 2016
• Last updated: April 5, 2017
• Start date: August 2016
• Est. completion date: February 1, 2017

Study information

• Verified date: April 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 1, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Neoplasms
• Metastatic Liver Cancer From Any Cancer Site
• Primary Liver Cancer

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure average motion trajectories		During MRI approx 1 hour
Primary	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
Primary	Image quality, as measured by tumor volume		During MRI approx 1 hour
Primary	Image quality, as measured by tumor-to-live contrast to noise ratio		During MRI approx 1 hour
Primary	Planning target volume (PTV)	PTV is defined as PTV=internal target volume (ITV) + safety margin (M)	During MRI approx 1 hour