Improving Pancreas Radiotherapy Plans Using Respiration-driven Anatomic Deformation: A Pilot Study

Study Overview
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Brief Summary
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The overall aim of this study is to investigate a novel dual instance planning method to make use of the respiratory motion to improve pancreatic radiation therapy (RT) treatment planning. Specific Aim 1: Acquire patient abdominal MRI and CT at both deep inspiration (INSP) and expiration (EXP) positions and characterize the changes in geometric relationships between the INSP and EXP instances for tumor and normal tissues including stomach, duodenum and bowel. We hypothesize that INSP and EXP MRI and CT characterization will allow identification of patients who may benefit from the dual instance planning method. Specific Aim 2: Develop, investigate and evaluate plans based on free breathing, single instance breath hold, and the novel dual instance anatomical information. We hypothesize that use of the dual instance method will lead to improved plans, demonstrated by the ability to increase dose to the target, while maintaining the clinically-accepted normal tissue dose constraints.

Official Title
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Improving Pancreas Radiotherapy Plans Using Respiration-driven Anatomic Deformation: A Pilot Study

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Other: Magnetic Resonance Imaging (MRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient with a biopsy proven diagnosis of malignancy involving the pancreas to be treated with radiation therapy Age >18 years Ability to understand and the willingness to sign a written informed consent document Creatinine or creatinine clearance of <1.5 times the upper limit of normal or >45 mL/min/1.73m2 for patients with creatinine levels above normal. Modification of Diet in Renal Disease (MDRD) formula was used to calculate the creatinine level Exclusion Criteria: Patients who are currently receiving any investigational agents Unable to undergo MRIs Patients with late stage kidney disease or who have had a liver transplant Individuals who are allergic to animal dander or have asthma that may be enflamed by proximity to animals will be excluded as the scans will take place in a facility where animal research is also performed.

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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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abdominal MRI<br>Subjects will undergo magnetic resonance imaging (MRI) with contrast. Magnetic resonance (MR)_freebreathing scan will be acquired. MR_inspiration scan will be acquired. MR_expiration scan will be acquired. | Other: Magnetic Resonance Imaging (MRI)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare magnetic resonance (MR) in different breath-hold phases to quantify respiration induced anatomic changes |  | Baseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modeling the feasibility of the dose escalation using respiration induced anatomic changes |  | Baseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic malignancy, Radiation Therapy