MR Guidance for Liver and Pancreas

Study Overview
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Brief Summary
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This is a single centre, single arm, prospective feasibility study that aims to see whether magnetic resonance imaging (MRI) as a source of image guidance before each radiation treatment fraction is feasible, and also if it may provide information that could potentially be used during the treatment to improve the radiation treatment plan. Patients will have 5 MRIs with each of their RT sessions. If patients' RT treatment will consist of more than 5 fractions, only 5 MRIs will be done with any 5 RT fractions. Patients will be completing a short questionnaire at the end of each MRI. A patient questionnaire will also be completed at the end of the study to assess for patient satisfaction. There will be 30 evaluable patients enrolled to the study.

Official Title
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A Feasibility Study of Magnetic Resonance Imaging (MRI) as a Platform for Image Guidance and Adaptive Radiation Therapy in Patients With Liver or Pancreatic Cancer

Conditions
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Magnetic Resonance Imaging

Intervention / Treatment
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* Other: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years or older Diagnosed with locally advanced pancreatic cancer or hepatocellular carcinoma being considered for treatment with chemoradiation, long course RT, or SBRT with curative intent or palliative intent, planned for 5 or more RT fractions Exclusion Criteria: - Contraindications for MRI: ferromagnetic prosthesis, pacemaker / implanted defibrillator, claustrophobia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pancreatic Cancer<br>Approximately 10 patients with pancreatic cancer will be enrolled to the study with the primary aim of determining the feasibility of using off-line MRI-guidance during the course of radiation treatment | Other: MRI<br>* Patients who consent to this study will have an abdominal MRI prior to or immediately after each fraction of radiation treatment in the case of those patients that are undergoing SBRT or those receiving palliative treatment. On patients receiving definitive chemoradiation, an abdominal MRI will be performed prior to or immediately after radiation treatment once per week during the any five weeks of treatment<br>|
| Liver Metastases<br>Approximately 10 patients with liver mets will be enrolled to the study with the primary aim of determining the feasibility of using off-line MRI-guidance during the course of radiation treatment | Other: MRI<br>* Patients who consent to this study will have an abdominal MRI prior to or immediately after each fraction of radiation treatment in the case of those patients that are undergoing SBRT or those receiving palliative treatment. On patients receiving definitive chemoradiation, an abdominal MRI will be performed prior to or immediately after radiation treatment once per week during the any five weeks of treatment<br>|
| Hepatocellular carcinoma<br>Approximately 10 patients with HCC will be enrolled to the study with the primary aim of determining the feasibility of using off-line MRI-guidance during the course of radiation treatment | Other: MRI<br>* Patients who consent to this study will have an abdominal MRI prior to or immediately after each fraction of radiation treatment in the case of those patients that are undergoing SBRT or those receiving palliative treatment. On patients receiving definitive chemoradiation, an abdominal MRI will be performed prior to or immediately after radiation treatment once per week during the any five weeks of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Survey | To evaluate patient satisfaction with the MR guidance process, a modified version of a questionnaire previously used at our institution will be performed at the end of the study | At study completion (day5 or week 5, depending on type of treatment) | 
| MRI-Anxiety Questionnaire | This instrument will be used to evaluate patient related anxiety after each MR | Prior to or before MR session 1 (day 1 or week 1, depending on type of treatment) | 
| MRI-Anxiety Questionnaire | This instrument will be used to evaluate patient related anxiety after each MR | Prior to or before MR session 2 (day 2 or week 2, depending on type of treatment) | 
| MRI-Anxiety Questionnaire | This instrument will be used to evaluate patient related anxiety after each MR | Prior to or before MR session 3 (day 3 or week 3, depending on type of treatment) | 
| MRI-Anxiety Questionnaire | This instrument will be used to evaluate patient related anxiety after each MR | Prior to or before MR session 4 (day 4 or week 4, depending on type of treatment) | 
| MRI-Anxiety Questionnaire | his instrument will be used to evaluate patient related anxiety after each MR | Prior to or before MR session 5 (day 5 or week 5, depending on type of treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Cancer, Pancreatic Cancer, Radiation