Using advanced MRI to measure tumor metabolism in patients with advanced solid tumors

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

This study is testing a new type of MRI to see if it can measure how tumors use energy in patients with advanced solid tumors after they receive standard treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT05599048 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of hyperpolarized 13C-pyruvate and 13C,15N-urea in metabolic magnetic resonance imaging to assess tumor metabolism in patients with advanced solid tumors. The study is divided into two phases: Phase I focuses on optimizing imaging techniques to detect metabolic signals, while Phase II evaluates changes in metabolic ratios after standard care treatments. Participants will undergo imaging to determine the safety and reproducibility of these metabolic markers as potential biomarkers for treatment response.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors that have measurable lesions suitable for imaging.

Not a fit: Patients with tumors that do not meet the size criteria or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive method to monitor tumor metabolism and treatment response, potentially leading to more personalized cancer therapies.

How similar studies have performed: Similar studies using metabolic imaging techniques have shown promise in assessing tumor response, suggesting potential success for this novel approach.

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,

Where this trial is running

San Francisco, California

• University of California, San Francisco — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Robert Bok, MD, PhD — University of California, San Francisco
• Study coordinator: Louise Magat

Conditions Advanced Solid Tumor; Biomarker