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Hyperpolarized 13C MRI for Pancreatic Cancer Response

This observational study is looking at a special type of MRI scan called hyperpolarized carbon-13 pyruvate (HP 13C MRI) to see how well it can predict treatment response in people with pancreatic cancer. This includes pancreatic ductal adenocarcinoma (PDA) that has spread locally or to other parts of the body (metastatic). You would receive hyperpolarized 13C-Pyruvate intravenously (through a vein) during the scan. Researchers want to see if changes in the HP 13C MRI scan, specifically how a tumor processes nutrients, are linked to how well your cancer responds to treatment. To join, you must be at least 18 years old and have confirmed PDA that is locally advanced or metastatic, with at least one measurable tumor in your abdomen. The study aims to measure how many participants show a good response to treatment and how the HP 13C lactate/pyruvate ratio changes over time.

Study design
This is an observational study with a planned enrollment of 70 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo a Computed Tomography (CT) scan and Magnetic Resonance Imaging (MRI) scans, including one with hyperpolarized 13C-Pyruvate given intravenously.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be measured for up to 24 months, and changes in the MRI scan will be measured for up to 6 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06600906

Hyperpolarized 13C MRI to Predict Response in Pancreatic Cancer

Recruiting
Not specifiedAges 18+Observational
University of California, San Francisco
~70 participants
Updated 2025-11-12 on ClinicalTrials.gov
What's tested:Hyperpolarized 13C-PyruvateComputed tomography (CT)Magnetic Resonance Imaging (MRI)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with best objective response (Cohorts A and B)
Measured over Up to 24 months
+3 more outcomes measured

Conditions

Pancreatic Ductal Adenocarcinoma
Metastatic Pancreatic Ductal Adenocarcinoma
Locally Advanced Pancreatic Ductal Adenocarcinoma

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Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of California, San Francisco

    San Francisco, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Zhen Wang, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Louise Magat
[email protected]
(415) 502-1822
Email the study team

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Eligibility criteria

Inclusion

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 willingness to sign a written informed consent document.

Exclusion

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.
Individuals of childbearing potential must agree to undergo a urine pregnancy test prior to participating in the study scans. Pregnant individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn child secondary to administration of HP 13C pyruvate to the study participant. A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (\>= 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries).
Participants who are breastfeeding/chestfeeding. Breastfeeding/chestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to administration of HP 13C pyruvate to the study participant. Breastfeeding/chestfeeding should be discontinued before administration of HP 13C pyruvate.
Known hypersensitivity to HP 13C pyruvate or any of its excipients.
Participants with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures

What this trial measures

  • Proportion of participants with best objective response (Cohorts A and B)Up to 24 months

    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 timeUp to 6 weeks

    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 timeUp to 6 weeks

    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).Up to 6 weeks

    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.