Clinical trial · Interventional
MRI-Guided Radiation Therapy for the Treatment of Early-Stage Kidney Cancer, the MRI-MARK Trial
MRI-Guided Stereotactic Body Radiotherapy for the Treatment of Early Stage Kidney Cancer: A Single Arm Phase II Clinical Trial (MRI-MARK)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): A study with 0 ACTUAL Enrollment must have Overall Recruitment Status specified as Withdrawn
Summary
Brief summary (as posted)
This phase II trial investigates how well MRI-guided stereotactic body radiation therapy works in treating patients with early-stage kidney cancer. Radiation therapy uses high energy radiation to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. This method of radiation delivery is further refined through the incorporation of a MRI into the radiation machine to create a device known as a MRI linear accelerator. During treatment with MRI linear accelerator, continuous MRI images are obtained to allow for real-time treatment monitoring and the ability to adjust treatment plans if minor deviations in anatomy are noted. Giving MRI-guided stereotactic body radiation therapy may help treat patients with early-stage kidney cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage II Renal Cell Cancer AJCC v8 | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage I Renal Cell Cancer AJCC v8 | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (MRI-guided SBRT)
- description
- Patients undergo an MRI scan to check the status and location of the disease, including the motion of the tumor during breathing. Two weeks after MRI, patients undergo SBRT over 1-2 hours on 3 non-consecutive weekdays in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Procedure: Magnetic Resonance Imaging
- Other: Questionnaire Administration
- Radiation: Stereotactic Body Radiation Therapy
Primary outcomes (1)
- measure
- Time to progression
- timeFrame
- at 24 months
- description
- Local control will be defined as no growth (stability or regression) in the largest dimension of the treated tumor by comparison of magnetic resonance imaging (MRI) images at baseline and 24 months following completion of stereotactic body radiation therapy (SBRT). The local control rate will be compared to case-matched data from patients undergoing active surveillance at MD Anderson Cancer Center. In terms of the primary efficacy analysis, the local control will be evaluated along with the 95% confidence interval. For patients who progress earlier than 24 months will be considered as local control failure and will be included in the confidence interval calculation. In addition, we will estimate the probabilities of local control utilizing the Kaplan Meier method with corresponding 95% confidence intervals.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients may enter the study if they are diagnosed with bilateral kidney cancer, multiple lesions in the same kidney, recurrent kidney cancer, or if they have previous or current history of a separate cancer, given all other inclusion criteria met * Have a pathologically confirmed diagnosis of renal cell carcinoma (RCC) of any histology * Be a suboptimal surgical or ablation candidate, as determined by patient's primary urologist at MD Anderson Cancer Center and by multi-disciplinary consensus. At or before the time of enrollment, a note documenting multidisciplinary consensus supporting active treatment will be recorded in the patient's chart * Tumor stage of T1-T2a (i.e. 10cm or less in greatest dimension) * Be technically and anatomically appropriate for MRI-guided SBRT, as determined by patient's primary radiation oncologist. Factors considered will include distance between tumor and bowel, tumor movement with respiration as assessed by 4-dimensional (4D) computed tomography (CT) scan, and prior radiotherapy * Multi-disciplinary consensus that active treatment is warranted * Have Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Have life expectancy of 2 years or more Exclusion Criteria: * An MRI contraindication (i.e. pacemaker, severe claustrophobia, or MRI-incompatible device) * 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 * Female subject of childbearing potential should have a negative urine or serum pregnancy within 6 weeks prior to study registration up to the first fraction of radiation * Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
References
Publications (0)
Data not yet available