NCT05599048 · Robert Bok, MD, PhD
Hyperpolarized 13C MRI as a Biomarker in Advanced Solid Tumors
What this study is about
This is a single center forward-looking imaging study investigating the utility of hyperpolarized 13C-pyruvate +/-13C,15N-Urea/ metabolic MR imaging. The current protocol will serve as a companion imaging biomarker study paired with the usual treatment (SOC) therapeutics, as well as experimental therapies that participants may be scheduled to receive outside of this protocol.
View original scientific description
This is a single center prospective imaging study investigating the utility of hyperpolarized 13C-pyruvate +/-13C,15N-Urea/ metabolic MR imaging. The current protocol will serve as a companion imaging biomarker study paired with standard of care (SOC) therapeutics, as well as investigational therapies that participants may be scheduled to receive outside of this protocol.
Interventions
DRUG
Hyperpolarized 13C-Pyruvate
Given IV
PROCEDURE
Magnetic Resonance Imaging (MRI)
Imaging procedure
DRUG
13C,15N-Urea
Given IV
Primary outcome measures
Signal-to-noise ratio (Part A)
Time frame: Day of imaging (1 day)
Signal-to-noise ratios is defined as a MR/spectroscopy parameter, consisting of the HP C13-Pyruvate or Lactate signal (peak) relative to background noise level (baseline) in MRI spectra of the tissue. For the analysis and interpretation of the HP 13C-pyruvate MR imaging data, DICOM software package (SIVIC) will be used to align, display and quantitatively interrogate serial multi-parametric imaging data.
Mean percent change from baseline in intratumoral HP pyruvate/lactate ratio
Time frame: Up to 25 days
Intra-tumoral region of interest (ROI) will be used to quantify peak HP lactate/pyruvate ratio values in the selected volumes of interest. Descriptive statistics will be used to characterize the mean change from baseline in intra-tumoral HP pyruvate/lactate ratio for the study cohort, along with a 95% confidence interval
Mean percent change from baseline in Urea Area Under Curve (AUC)
Time frame: Up to 25 days
Intra-tumoral region of interest (ROI) will be used to quantify urea AUC. Descriptive statistics will be used to characterize the mean change from baseline in Urea Area Under Curve (AUC)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Presence of at least one target pelvic, abdominal, thoracic, neck or extremity lesion detected by standard staging scans that, in the judgment of study investigator, would be amenable to hyperpolarized C-13 pyruvate/metabolic MR imaging: a. Target lesion must measure at least 1.0 cm in long axis diameter on Computerized tomography (CT) or magnetic resonance imaging (MRI).
- The participant is able and willing to comply with study procedures and provide signed and dated informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Adequate renal function defined as creatinine \< 1.5 x upper limit of normal (ULN) or estimated creatinine clearance \>50 mL/min (by the Cockcroft Gault equation).
- Participants age 18 and older. Part B only:
- Planned treatment for disease with either standard of care regimen or an investigational agent.
Exclusion criteria
- Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
- Patients with contra- indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
- Patients with a metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging.
- Patients with poorly controlled hypertension, defined as systolic blood pressure at study entry greater than 160mm Hg or diastolic blood pressure greater than 100mm Hg. Note: The addition of anti-hypertensives to control blood pressure is allowed.
- Patients with congestive heart failure or New York Heart Association (NYHA) status \>= 2.
- Patients who are pregnant or lactating.
- A history of clinically significant EKG abnormalities or myocardial infarction (MI) within 6 months of study entry. Note: Patients with rate-controlled atrial fibrillation/flutter will be allowed on study.
- Any condition that, in the opinion of the Principal Investigator,
Where
- San Francisco, California
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Cancer Institute (NCI), Sigma-Aldrich
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 27, 2026 · Source of record for eligibility and locations