Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
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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