Clinical trial NCT02019199: Magnetic Resonance Imaging (MRI) in Motion
Official title: Magnetic Resonance Imaging ( MRI) for Radiation Therapy Treatment Planning Evaluation of Lung, Liver and Pancreatic Motion.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cancer, Lung Cancer, Pancreatic Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults males or females with primary or secondary cancer tumors of the lung, liver or pancreas

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the accuracy, robustness, and efficacy of MRI for tumor motion measurement.
timeFrame: During MRI approx 1 hour
measure: Tumor volume
timeFrame: During MRI approx 1 hour
measure: Tumor contrast-to-noise ratio (CNR)
timeFrame: During MRI approx 1 hour
measure: Tumor Motion
timeFrame: During MRI approx 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Brian Czito, MD
role: PRINCIPAL_INVESTIGATOR
References: