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.
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.
Participants unwilling or unable to undergo magnetic resonance (MR) imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
Poorly controlled hypertension, defined as either systolic > 170 or diastolic > 110. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.
Congestive Heart Failure ≥ Class III.
Participants who are pregnant.
Adults receiving standard of care at University of California, San Francisco with biopsy-proven locally advanced or metastatic pancreatic ductal adenocarcinoma.
Case-only
Prospective
Hyperpolarized 13C-Pyruvate
DrugGiven intravenously (IV)
Computed tomography (CT)
Procedure/SurgeryUndergo CT imaging
Magnetic Resonance Imaging (MRI)
Procedure/SurgeryUndergo MRI imaging
Proportion of participants with best objective response (Cohorts A and B)
The best objective response based on clinical imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.11 will be reported
Mean percent change in target tumor peak HP 13C lactate/pyruvate ratio over time
The mean percent change in peak HP 13C lactate/pyruvate ratio with 95% confidence intervals (CI) will be reported for scans completed at baseline and after 4 weeks (+/- 2 weeks) of non-interventional, standard of care treatment.
Mean change in target tumor HP 13C lactate/pyruvate area under the curve (AUC) ratio over time
The mean change in HP 13C lactate/pyruvate area under the curve (AUC) ratio will be reported for scans completed at baseline and scans after 4 weeks (+/- 2 weeks) of non-interventional, standard of care treatment.
Mean percent change in target tumor HP 13C pyruvate to lactate conversion rate (kPL).
The mean percent change in pyruvate to lactate conversion rate (kPL) will be reported for scans completed at baseline and scans after 4 weeks (+/- 2 weeks) of non-interventional, standard of care treatment.
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University of California, San Francisco
Lead sponsor
National Cancer Institute (NCI)
Collaborator
