NCT05599048 Hyperpolarized 13C MRI as a Biomarker in Advanced Solid Tumors
| NCT ID | NCT05599048 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Robert Bok, MD, PhD |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2022-12-15 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 65 participants in total. It began in 2022-12-15 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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,
Contact & Investigator
Robert Bok, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT05599048 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05599048 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05599048 currently recruiting?
Yes, NCT05599048 is actively recruiting participants. Contact the research team at Louise.Magat@ucsf.edu for enrollment information.
Where is the NCT05599048 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT05599048 clinical trial?
NCT05599048 is sponsored by Robert Bok, MD, PhD. The principal investigator is Robert Bok, MD, PhD at University of California, San Francisco. The trial plans to enroll 65 participants.