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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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.
. 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.