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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02722395

Enrollment

Registered

2016-03-30

Start date

2016-08-31

Completion date

2017-02-01

Last updated

2017-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Liver Cancer From Any Cancer Site, Primary Liver Cancer

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Measure average motion trajectories	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.
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)	During MRI approx 1 hour	PTV is defined as PTV=internal target volume (ITV) + safety margin (M)

Countries

United States

Outcome results