Hyperpolarized 13C Pyruvate MRI Scan in Predicting Tumor Aggressiveness in Patients With Renal Tu… (NCT04258462) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Hyperpolarized 13C Pyruvate MRI Scan in Predicting Tumor Aggressiveness in Patients With Renal Tumors
United States54 participantsStarted 2019-01-15
Plain-language summary
This feasibility study will evaluate how well hyperpolarized 13C pyruvate magnetic resonance imaging (MRI) scan works in predicting tumor aggressiveness in participants with renal tumors. Hyperpolarized 13C pyruvate is a non-radioactive substance with potential usage in the diagnostic imaging of tumors. Hyperpolarized 13C pyruvate MRI may help doctors determine non-invasively whether a kidney tumor is a benign tumor or cancer, and if cancer, how aggressive it is. This may help doctors and participants with renal tumors in the future to make better treatment decisions.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
✓. The participant is able and willing to comply with study procedures and provide signed and dated informed consent.
✓. The participant is willing to undergo standard of care abdominal MRI in connection with the study exam.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion criteria
✕. Participants who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
✕. 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.
What they're measuring
1
Comparison between HP 13C pyruvate-to-lactate conversion, as measured by peak lactate/pyruvate ratio with tumor histology and grade.
Timeframe: Up to 12 months
2
Comparison between HP 13C pyruvate-to-lactate conversion, as measured by the lactate /pyruvate area under curve (AUC) with tumor histology and grade.
Timeframe: Up to 12 months
3
Comparison between HP 13C pyruvate-to-lactate conversion, as measured by the apparent rate of constant metabolic flux of HP 13C-pyruvate to lactate (kPL), with tumor histology and grade.
✕. Any metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging of the abdomen.
✕. Prior focal therapy (i.e. ablation) for the renal tumor.
✕. 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.
✕. Congestive heart failure or New York Heart Association (NYHA) status \>= 2.