Phase 2 Elekta Unity MR-linac MR-guided SBRT (MRgRT) for localized renal cell carcinoma

NYU Langone Health is running this single-arm Phase 2 study testing whether MRI-guided, online-adaptive stereotactic body radiation therapy (SBRT) delivered on the Elekta Unity MR-guided linear accelerator can achieve low rates of clinically meaningful toxicity while maintaining local control in early-stage kidney cancer. The intervention is MRgRT: high-field MRI guidance plus adaptive replanning and respiratory gating to better account for kidney motion and daily anatomy changes, aiming to tighten margins and spare bowel, stomach, and remaining functional kidney. Eligible patients have cT1a–T1b, cN0, cM0 renal tumors (renal cell carcinoma/solid tumor primary), specifically those considered suboptimal candidates for surgery or ablation or who decline those options. The regimen is ultra-hypofractionated SBRT (26 Gy in 1 fraction to an MR-defined target volume), with dosimetry and CTCAE v6.0 grade 2+ adverse events as key outcomes. The commercial/scientific angle is “hardware-enabled precision”: Elekta’s MR-linac platform makes real-time MR visualization and on-table plan adaptation practical, potentially improving the therapeutic ratio in a disease where today’s care is partial nephrectomy when feasible, or percutaneous ablation/active surveillance for select small renal masses, with conventional CT-guided SBRT emerging mainly for nonoperative patients.