Recruiting
Phase 1
Phase 2

Hyperpolarized 13C Pyruvate

Sponsor:

Robert Bok, MD, PhD

Code:

NCT05599048

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized 13C-Pyruvate

Magnetic Resonance Imaging (MRI)

13C,15N-Urea

Study Details

Brief summary:

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.

Conditions

Advanced Solid Tumor

Study ID

NCT05599048

Start date

Dec 15, 2022

Status verified date

Mar, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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).
2. The participant is able and willing to comply with study procedures and provide signed and dated informed consent.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
4. 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).
5. Participants age 18 and older.

Part B only:
6. Planned treatment for disease with either standard of care regimen or an investigational agent.

Exclusion Criteria:

1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
2. Patients with contra- indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
3. Patients with a metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging.
4. 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.
5. Patients with congestive heart failure or New York Heart Association (NYHA) status >= 2.
6. Patients who are pregnant or lactating.
7. 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.
8. Any condition that, in the opinion of the Principal Investigator,

Study Design

Enrollment

65 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A / Phase 1: Feasibility Run-In

Participants will undergo MR imaging at a single time point. Imaging will take one day and no follow up is planned.

experimental: Part B/ Phase II: Biomarker Cohort

Participants will undergo paired 13C-pyruvate +/- 13C,15N-urea/metabolic MR imaging at baseline and again after approximately 21 days of therapy. Duration of the intervention period is approximately 21 days, and participants will be followed until discontinuation of their current SOC treatment regimen, about 6 months.

Interventions

Hyperpolarized 13C-Pyruvate

Given IV

Magnetic Resonance Imaging (MRI)

Imaging procedure

13C,15N-Urea

Given IV

Primary outcome measure

  • Signal-to-noise ratio (Part A) [ Time Frame: Day of imaging (1 day) ]
  • Mean percent change from baseline in intratumoral HP pyruvate/lactate ratio [ Time Frame: Up to 25 days ]
  • Mean percent change from baseline in Urea Area Under Curve (AUC) [ Time Frame: Up to 25 days ]

Central Contacts and Locations

Central contacts

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Robert Bok, MD, PhD

More Information

Sponsor

Robert Bok, MD, PhD

Last update posted

May 27, 2026

Last verified

Mar, 2026

Keywords

  • Biomarker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Robert Bok, MD, PhD on 2026-05-27.