Using MRI to predict tumor aggressiveness in kidney tumors

Hyperpolarized 13C Pyruvate Metabolic MRI to Predict Renal Tumor Aggressiveness

This study is testing if a special MRI technique can help doctors predict how aggressive kidney tumors are, which could help in deciding the best treatment for patients.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT04258462 on ClinicalTrials.gov

What this trial studies

This feasibility study evaluates the effectiveness of hyperpolarized 13C pyruvate magnetic resonance imaging (MRI) in predicting the aggressiveness of renal tumors. The study aims to determine the relationship between the conversion of hyperpolarized 13C pyruvate to lactate and the histological characteristics of renal tumors, including benign tumors and renal cell carcinoma (RCC). Participants will receive hyperpolarized 13C pyruvate intravenously, and the study will also assess the reproducibility and safety of this imaging technique. The findings may help guide treatment decisions for patients with renal tumors.

Who should consider this trial

Good fit: Ideal candidates are individuals with renal tumors measuring 1 cm or greater who are being considered for management options like nephrectomy, ablation, or active surveillance.

Not a fit: Patients with renal tumors smaller than 1 cm or those not eligible for the specified management options may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enable non-invasive differentiation between benign and malignant kidney tumors, leading to more informed treatment decisions.

How similar studies have performed: While the use of hyperpolarized MRI is a novel approach, similar imaging techniques have shown promise in other tumor types, suggesting potential for success in this context.

Eligibility criteria

Inclusion Criteria:

1. Renal tumor measuring 1 cm and greater in diameter. To minimize any potential partial volume effects in this pilot study, the investigators have limited the lower size range of the tumor to 1 cm. The investigators will include all renal tumor measuring 1 cm and greater in diameter in this first study to facilitate obtaining tumors of a range of histology and grade.
2. The participant is being considered by the treating physician to have any of the following management options: partial or radical nephrectomy, ablation, or active surveillance for his/her renal tumor.
3. The participant is able and willing to comply with study procedures and provide signed and dated informed consent.
4. The participant is willing to undergo standard of care abdominal MRI in connection with the study exam.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

1. Participants who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
2. Participants unwilling or unable to undergo magnetic resonance (MR) imaging, including patients with contra-indications to MR imaging, such as cardiac pacemakers or non-compatible intracranial vascular clips.
3. Any metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging of the abdomen.
4. Prior focal therapy (i.e. ablation) for the renal tumor.
5. Poorly controlled hypertension, with blood pressure at study entry \>160/100. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.
6. Congestive heart failure or New York Heart Association (NYHA) status \>= 2.

Where this trial is running

San Francisco, California

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

Study contacts

• Principal investigator: Zhen Jane Wang, MD — University of California, San Francisco
• Study coordinator: Zhen Jane Wang, MD

Conditions Benign Kidney Neoplasm; Kidney Neoplasm; Renal Cell Cancer