About this trial
The purpose of this study is to investigate the use of an MR-guided linear accelerator to treat early stage renal cancer patients, considered inoperable or in patients declining surgerys. The study will collect efficacy, toxicity, and dosimetry data and assess the degree of improvement provided by this treatment technique. The primary objective is to evaluate whether magnetic resonance imaging (MRI)-guided radiation therapy (MRgRT) for primary renal cancer has an improved toxicity profile relative to conventional computed tomography (CT) based radiation therapy, as measured by the frequency of grade 2+ adverse events following MRgRT as per Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Eligibility criteria
Qualifiers
Patients at or over 18 years old.
Patients may enter the study if they are diagnosed with bilateral kidney cancer, recurrent kidney cancer, or if they have previous or current history of a another primary cancer, given all other inclusion criteria met.
Have a pathologically confirmed diagnosis of renal cell carcinoma (RCC) of any histology, or radiographic diagnosis if biopsy is not clinically indicated, consistent with standard clinical practice where imaging findings provide sufficient diagnostic certainty. In such cases, biopsy may not be required to avoid additional procedural risk; however, inclusion of patients without histologic confirmation may introduce some diagnostic uncertainty, which will be considered in the interpretation of study results.
Patients must be deemed a suboptimal surgical or ablation candidate, as determined by the patient's primary urologist at NYU Langone Health and confirmed by multidisciplinary consensus, or may be individuals who decline surgery or ablation following appropriate clinical evaluation and discussion..
Disqualifiers
An MRI contraindication (e.g. severe claustrophobia or MRI-incompatible device). In the event of mild claustrophobia, patients will be permitted to take anti-anxiety medication as required for simulation and treatment.
A pre-treatment estimated glomerular filtration rate < 30 cc/min.
Visceral, nodal, or bony metastatic disease.
Is pregnant or expecting to conceive within the projected duration of the trial at the screening visit.
Trial design
Treatments tested in this trial
- MRI-guided linear accelerator
- Magnetic resonance imaging (MRI)-guided radiation therapy (MRgRT)