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RecruitingAdvanced Solid Tumor

Hyperpolarized 13C MRI as a Biomarker in Advanced Solid Tumors

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: Robert Bok, MD, PhD

You may qualify if…

  • ✓ 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.

You may not qualify if…

  • ✕ 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.

Where it's recruiting

California

San Francisco

Source: ClinicalTrials.gov · NCT05599048 · last updated 2026-05-27