Stereotactic MR-Adaptive Radiation Therapy for Early-stage Renal Cancer

Conditions

• Primary Renal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• MRI-guided linear accelerator — DEVICE
  MRI images are obtained before treatment, for adaptive planning, as well as in real-time, to allow for motion monitoring and respiratory gating.
• Magnetic resonance imaging (MRI)-guided radiation therapy (MRgRT) — RADIATION
  The patients will be treated using an MR-guided approach with adaptive online replanning and respiratory gating using an Elekta Unity MR linac system. Stereotactic Body Radiotherapy (SBRT) will be delivered with a prescription dose of 26Gy in 1 fraction to the PTV\_26 volume as defined by MR imaging.

Study Details

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.

Key Dates

First listed

Aug 17, 2026

Start date

Aug 19, 2026

Status verified

Aug 2026

Primary completion

Oct 31, 2029

Completion

Oct 31, 2030

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Early stage renal cancer
  The patients will be treated using an MR-guided approach with adaptive online replanning and respiratory gating using an Elekta Unity MR linac system. SBRT will be delivered with a prescription dose of 26Gy in 1 fraction to the PTV\_26 volume as defined by MR imaging. Treatment occurs over 1 hour on 1 weekday, taking approximately 1 hour to deliver the radiation with around 45 minutes of planning.

Primary Outcome Measure

Number of grade 2 or higher toxicity events [ Time Frame: Up to 12 months after completion of treatment ]

Central Contacts

• Nicholas Colangelo, MD, PhD
  212-731-5003
  [email protected]

Locations (1)

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