Actively Recruiting
Translating Hyperpolarized 13C MRI as a Novel Tool to Predict Treatment Response in Pancreatic Cancer
Led by University of California, San Francisco · Updated on 2025-11-12
70
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating an experimental scan called hyperpolarized carbon-13 pyruvate magnetic resonance imaging (MRI) to assess treatment response in patients with pancreatic ductal adenocarcinoma (PDA) that has spread locally or to other parts of the body. This investigational MRI uses a special contrast agent that shows how tumors process nutrients, potentially providing better information than standard MRI scans with usual contrast agents. The study aims to see if this scan can predict how PDA tumors respond to treatment and relate these changes to tumor size and patient outcomes. Participants are assigned to one of two groups based on their disease status. Those with advanced or non-resectable PDA receive the investigational agent intravenously and undergo MRI scans before starting standard treatment, then again 4 weeks after treatment begins, with an optional scan at 8 weeks. Patients with localized PDA who are candidates for neoadjuvant therapy undergo similar MRI scans before and after starting therapy, with the same optional 8-week scan. Throughout the study, participants also have CT and additional MRI scans, and may move between groups depending on their response and surgical eligibility. During the study, participants undergo imaging assessments including the investigational MRI and CT scans to measure tumor metabolism and size. Researchers track changes in tumor metabolism measures at multiple timepoints and relate these to treatment response using established criteria and survival outcomes. The study also evaluates the repeatability of the investigational scan and compares it with other MRI measures. Participants' health and ability to undergo scans are monitored, and the study may last up to 24 months to assess long-term outcomes.
CONDITIONS
Brief Title
Hyperpolarized 13C MRI to Predict Response in Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 �3E= 1 centimeter, according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 (Karnofsky �3E= 50%).
- Participants with prior or concurrent malignancy are eligible if it does not interfere with safety or study endpoints.
- Ability to understand and willingness to sign informed consent.
You will not qualify if you...
- Unable or unwilling to undergo MRI, including those with pacemakers or incompatible intracranial clips.
- Poorly controlled hypertension (systolic > 170 or diastolic > 110).
- Congestive Heart Failure Class III or higher.
- Pregnant individuals.
- Breastfeeding or chestfeeding individuals.
- Known allergy to hyperpolarized 13C pyruvate or its components.
- Any condition or social situation that would impair ability to comply with study procedures.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks following treatment initiation
Participants undergo hyperpolarized 13C pyruvate MRI scans and CT scans to monitor tumor metabolism and size before and during treatment.
2 to 3 MRI visits and multiple CT scans during this period
Duration - Up to 24 months
Participants are observed with additional MRI and CT scans to evaluate treatment response and disease progression over time.
Periodic imaging visits as scheduled during follow-up
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
L
Louise Magat
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here