Hyperpolarized 13C MRI As a Biomarker in Advanced Solid Tumors

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.

Conditions

Advanced Solid Tumor

Study Overview

Study Details

Study overview

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.

A Phase I/II Study of Hyperpolarized 13C MRI As a Biomarker of Aggressiveness & Response to Therapy in Patients with Advanced Solid Tumors

Hyperpolarized 13C MRI As a Biomarker in Advanced Solid Tumors

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • 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.
  • 6. Planned treatment for disease with either standard of care regimen or an investigational agent.
  • 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.
  • 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.
  • 8. Any condition that, in the opinion of the Principal Investigator,

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Robert Bok, MD, PhD,

Robert Bok, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2026-01-31