Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05599048

Hyperpolarized 13C MRI as a Biomarker in Advanced Solid Tumors

Led by Robert Bok, MD, PhD · Updated on 2025-03-24

65

Participants Needed

1

Research Sites

163 weeks

Total Duration

On this page

Sponsors

R

Robert Bok, MD, PhD

Lead Sponsor

N

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Hyperpolarized 13C MRI as a Biomarker in Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of at least one target pelvic, abdominal, thoracic, neck, or extremity lesion measuring at least 1.0 cm in long axis on CT or MRI
  • Ability and willingness to comply with study procedures and provide signed informed consent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate renal function with creatinine < 1.5 times upper limit of normal or creatinine clearance > 50 mL/min
  • Age 18 years or older
  • For Part B only: planned treatment with standard of care regimen or investigational agent
Not Eligible

You will not qualify if you...

  • Unable to give valid informed consent due to age, medical or psychiatric condition, or physiologic status
  • Contraindications to MRI, including cardiac pacemakers or non-compatible intracranial vascular clips
  • Metallic implants or devices that distort the magnetic field and affect MRI quality
  • Poorly controlled hypertension with systolic > 160 mm Hg or diastolic > 100 mm Hg (antihypertensives allowed)
  • Congestive heart failure or New York Heart Association (NYHA) status ≥ 2
  • Pregnant or lactating women
  • History of significant EKG abnormalities or myocardial infarction within 6 months (rate-controlled atrial fibrillation/flutter allowed)
  • Any condition that the Principal Investigator considers inappropriate for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

L

Louise Magat

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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