Magnetic Resonance Imaging (MRI) to Predict Outcomes of Pancreatic Ductal Adenocarcinoma (PDAC)

Study Overview
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Brief Summary
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The purpose of this study is to assess if Six-Dimensional Magnetic Resonance Imaging (6D-MRI) is effective in predicting outcomes in patients with pancreatic ductal adenocarcinoma (PDAC).

Detailed Description
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The overarching goal of this pilot study is to evaluate the usefulness of a novel Magnetic Resonance Imaging (MRI) approach, which measure properties of tumor microenvironment (i.e. vascularity, fibrosis), to predict PDAC response to neoadjuvant therapy (NAT).

Official Title
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MRI Imaging to Predict Outcomes of Treatment in PDAC Patients

Conditions
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PDAC - Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Diagnostic Test: 6D-MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pancreatic cancer patients (with resectable or borderline resectable or locally advanced tumors) who will undergo neoadjuvant chemotherapy Patients able to undergo at least two sets of MRI sessions Access to a device that has the capability to sync to the Fitbit (or access to a family member's, caregiver's, or friend's device) Exclusion Criteria: Patients who have previously been treated for PDAC Patients unable to undergo MRI exam w/contrast Patients with metastatic pancreatic cancer visualized on index diagnostic imaging Patients with certain metallic implants Patients experiencing 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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6D-MRI<br>Participants will undergo 6D-MRI imaging three times throughout the course of the study: once pre-NAT treatment, once during NAT treatment, and once post-NAT treatment. | Diagnostic Test: 6D-MRI<br>* Six-Dimensional Quantitative Dynamic Contrast Enhanced MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of progression-free survival from baseline | Progression-free survival will be determined by tumor activity assessed from radiomic features on imaging. | 2 years | 
| Number of participants with R0 resection | The rate of negative tumor resection margins for patient's with resectable cancer that undergo surgery. | 2 years | 
| Change in overall health from baseline, as measured by the Charlson Comorbidity Index (CCI) | Scores are summed depending on the patient's age and the presence of certain comorbidities. Lower scores are correlated to higher overall survival rates. | Baseline, 2 years | 
| Change in functional status from baseline, as measured by the Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status | Scores range from 0 to 4, with 0 denoting fully active and 1-4 for varying degrees of disability. | Baseline, 2 years |