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

NCT02722395 | Completed

• 1 other identifier: Pro00071159
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Primary Liver Cancer; Metastatic Liver Cancer From Any Cancer Site

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Single arm cohort study

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Brian Czito

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 30, 2016
• Study Start: August 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 6, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)