Magnetic Resonance Imaging (MRI) in Motion

Liver Cancer, Lung Cancer, Pancreatic Cancer Clinical Trial

Official title:

Magnetic Resonance Imaging ( MRI) for Radiation Therapy Treatment Planning Evaluation of Lung, Liver and Pancreatic Motion.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02019199
• Other study ID #: Pro00032595
• Status: Completed
• Phase: N/A
• First received: December 18, 2013
• Last updated: July 7, 2017
• Start date: November 2011
• Est. completion date: August 2015

Study information

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

Clinical Trial Summary

This study is a research initiative established to explore the use of magnetic resonance imaging (MRI) as a tool for detecting organ motion as it pertains to planning radiation therapy.

Description:

The goal with radiation therapy is to treat the defined tumor and spare the surrounding normal tissue from receiving dose above specified tolerance doses. There is evidence of improved local control and survival with higher doses of radiation, however, at the same time there is the need to spare normal tissues from higher doses of radiation. Technologies that allow the delivery of an increased radiation dose to the tumor while sparing normal tissue have the potential of improving the therapeutic ratio. However, the development of these technologies has been hampered by organ respiratory motion particularly in the case of the lungs and liver. Inadequate radiation coverage of a tumor secondary to organ motion can lead to delivering a lower dose to a portion of the tumor. Making the field of radiation larger to account for organ motion results in unnecessary radiation dose to surrounding healthy tissues. It is therefore desirable to document the extent of motion of the organ in question prior to carrying out the radiation treatment planning. The organ motion impacts directly on the radiation dose distribution in the treatment volume.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Age = 21

• Patients with primary or metastatic tumors in the lungs, liver, or pancreas

• Patients undergoing a planning CT scan in the Department of Radiation Oncology with tumor motion assessment - planning 4D-CT ordered by the treating Radiation Oncologist

• Signed, specific informed consent prior to study entry

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, etc

• Pregnant or breast-feeding women

• Subjects who have difficulty lying flat on their back for extended periods of time

Related Conditions & MeSH terms

• Liver Cancer, Lung Cancer, Pancreatic Cancer
• Liver Neoplasms
• Lung Neoplasms
• Pancreatic Neoplasms

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	To evaluate the accuracy, robustness, and efficacy of MRI for tumor motion measurement.	MRI and CT ( all subjects will have a standard of care CT scan) data in DICOM format will be collected for analysis using commercial or customized - developed software. Image quality will be assessed based on signal-to-noise (SNR), contrast-to-noise ratio (CNR), and the presence of image artifacts. Data to be computed include, but are not limited to, tumor volumes (gross tumor volume, internal target volume, planning target volume, etc.), tumor motion parameters (range, trajectory, frequency, variation, probability distribution, etc.), and treatment plan parameters (target coverage, dose-volume-histogram, etc.).	During MRI approx 1 hour
Primary	Tumor volume	Free breathing/breath-hold MRI will be compared to free breathing/breath-hold CT	During MRI approx 1 hour
Primary	Tumor contrast-to-noise ratio (CNR)	Difference between CNR is measured by 4D-MRI and 4D-CT	During MRI approx 1 hour
Primary	Tumor Motion	Difference between tumor motion as measured by 2D cine-MRI vs 4D-MRI vs 4D-CT	During MRI approx 1 hour