Hyperpolarized 13C Pyruvate MRI Scan in Predicting Tumor Aggressiveness in Patients With Renal Tumors

Launched by ZHEN WANG, MD · Feb 4, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to use a special type of MRI scan called hyperpolarized 13C pyruvate MRI to help doctors understand how aggressive kidney tumors might be. The goal is to see if this non-radioactive imaging technique can help determine whether a kidney tumor is benign (not cancerous) or cancerous, and if it is cancer, how serious it might be. This information could help doctors and patients make better decisions about treatment options.

To participate in this study, you need to have a kidney tumor that is at least 1 cm in size and be considering treatment options like surgery or monitoring. You should also be able to follow the study procedures and give your consent. People who have certain medical conditions or devices that might interfere with the MRI, or those who have had previous treatments for their kidney tumor, may not be eligible. If you join the trial, you can expect to undergo an MRI scan as part of the study, and this could help pave the way for better understanding and treatment of kidney tumors in the future.

Gender

ALL

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.