Hyperpolarized 13C MRI to Predict Response in Pancreatic Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Hyperpolarized 13C-Pyruvate
  • Computed tomography (CT)
  • Magnetic Resonance Imaging (MRI)

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of California, San Francisco

Lead sponsor

National Cancer Institute (NCI)

Collaborator