Actively Recruiting

Age: 18Years +
All Genders
ID06600906

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Long-term Monitoring

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

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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

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