University of California, San Francisco
This study evaluates an investigational scan called hyperpolarized carbon-13 pyruvate magnetic resonance imaging (MRI) in assessing treatment response in patients with pancreatic ductal carcinoma (PDA) that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). MRI is a standard scan that helps doctors see tumors, organs, tissue, and bone. Standard contrast agents (e.g., gadolinium) are sometimes used to help make the scan images brighter, or easier to see. Hyperpolarized carbon-13 pyruvate is an experimental contrast agent that is different from standard MRI contrast in that it provides information on how a tumor processes nutrients. Hyperpolarized carbon-13 pyruvate MRI scans may work better than MRI with standard contrast agents in predicting how PDA tumors respond to treatment.
PRIMARY OBJECTIVES: I. To determine the percent changes in target tumor (primary tumor and/or abdominal metastases) hyperpolarized carbon C 13 pyruvate (HP 13C pyruvate) metabolism measures between the pre-treatment scan and the scan obtained 4 weeks (± 2 weeks) following treatment initiation. (Cohorts A and B). II. To determine whether the changes in these metabolism measures are associated with best objective response (as defined by Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\]1.1) on subsequent clinical computed tomography (CT) scans. (Cohorts A and B). SECONDARY…
Inclusion Criteria: * Participants must be 18 years or older. * Histological or cytological confirmation of pancreatic ductal adenocarcinoma (PDA). * Locally advanced or metastatic disease. * At least one target lesion in the abdomen measuring ≥ 1centimeter (cm), according to RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 (Karnofsky ≥ 50%) * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible. * Ability to understand and w…
Given intravenously (IV)
Undergo CT imaging
Undergo MRI imaging
Arctuva estimate
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