Primary Renal CancerSMARTERNCT07767500
Stereotactic MR-Adaptive Radiation Therapy for Early-stage Renal Cancer
A study testing MRI-guided linear accelerator and Magnetic resonance imaging (MRI)-guided radiation therapy (MRgRT) in people with Primary Renal Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Renal Cancer
- What is being tested?
- MRI-guided linear accelerator and Magnetic resonance imaging (MRI)-guided radiation therapy (MRgRT)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2026to Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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..
- o 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 cT1a-b, cN0, M0 (i.e. less than 7 cm in greatest dimension).
Show all 10Show fewer
- Be technically and anatomically appropriate for MRI-guided radiation therapy, as determined by patient's primary radiation oncologist.
- o Factors considered will include distance between tumor and bowel, tumor movement with respiration as assessed by 4-dimensional (4D) imaging, and prior radiotherapy in close proximity to treatment which would lead to high dose overlap from the prior radiation fields.
- Have Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Have life expectancy of 2 years or more.
Who cannot join
- 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.
- Pregnant or breastfeeding individuals, or individuals of childbearing potential who have a positive pregnancy test at screening or prior to radiation treatment initiation.
- Individuals of childbearing potential who are unwilling to use one highly effective method of contraception and one additional effective method of contraception, or abstain from heterosexual intercourse, during study participation and for 6 months after completion of study therapy.
Show all 10Show fewer
- Previous high dose radiation treatment to an overlapping area.
- 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.
- Is on systemic therapy that is reasonably expected to modify radiation sensitivity and cannot be stopped for a sufficient washout period to allow for radiation treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: A Phase II Single-Arm Study Evaluating Toxicity, Outcomes, and Dosimetry Using an MR-guided Linear Accelerator for the Treatment of Early Stage Kidney Cancer
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.
- Conditions
- Primary Renal Cancer
- Being tested
- MRI-guided linear accelerator, Magnetic resonance imaging (MRI)-guided radiation therapy (MRgRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-guided linear acceleratorDevice
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
Also called Elekta Unity MR linac system
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 group | Role | What they receive |
|---|---|---|
| Early stage renal cancer | Experimental | 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. Receives: Device: MRI-guided linear accelerator; Radiation: Magnetic resonance imaging (MRI)-guided radiation therapy (MRgRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of grade 2 or higher toxicity events
Determined as the frequency of grade 2+ adverse events following treatment as per Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Measured: Up to 12 months after completion of treatment
Secondary outcomes (8)
Change in glomerular filtration rate
Measured: Baseline, Month 12
Number of treatment related toxicities
This will provide a broader perspective of toxicity by including the Grade 1 toxicities, relative to the primary endpoint.
Measured: Up to 12 months after completion of treatment
Progression free survival
PFS is defined as the time from initiation of treatment to disease progression or death from any cause.
Measured: Month 12
Distant metastasis-free survival
Defined as the length of time after treatment that a patient lives without the cancer spreading to distant organs or parts of the body.
Measured: Month 12
Overall survival
OS is defined as the time from initiation of treatment to death from any cause.
Measured: Month 12
Number of doses that were planned and delivered
Measured: Up to 3 months
Number of normal tissue true delivered doses with grade 3+ toxicity at 12 months after completion of MRgRT
Measured: 12 months after completion of treatment
Rate of cases in which the prescribed isodose line failed to cover 95% of the gross tumor volume (GTV)
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start19 Aug 2026
- Primary completionOct 2029 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Renal CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Colangelo, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767500
- Sponsor's protocol ID
- 25-01521
- Acronym
- SMARTER
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Nicholas.Colangelo@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single-Arm Study Evaluating Toxicity, Outcomes, and Dosimetry Using an MR-guided Linear Accelerator for the Treatment of Early Stage Kidney Cancer
- ClinicalTrials.gov ID
- NCT07767500
- Acronym / sponsor ID
- SMARTER / 25-01521
- Conditions
- Primary Renal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early stage renal cancer | Experimental | Device: MRI-guided linear accelerator, Radiation: Magnetic resonance imaging (MRI)-guided radiation therapy (MRgRT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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..
- o At or before the time of enrollment, a note documenting multidisciplinary consensus supporting active treatment will be recorded in the patient's chart.
Key exclusion criteria (10 listed)
- 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.
- Pregnant or breastfeeding individuals, or individuals of childbearing potential who have a positive pregnancy test at screening or prior to radiation treatment initiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI-guided linear acceleratorMRI images are obtained before treatment, for adaptive planning, as well as in real-time, to allow for motion monitoring and respiratory gating. | Device | Early stage renal cancer |
| Magnetic resonance imaging (MRI)-guided radiation therapy (MRgRT)Also: Elekta Unity MR linac systemThe 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. | Radiation | Early stage renal cancer |
Primary outcome
Number of grade 2 or higher toxicity events
Time frame: Up to 12 months after completion of treatment
Determined as the frequency of grade 2+ adverse events following treatment as per Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
8 secondary outcomes
Change in glomerular filtration rate
Time frame: Baseline, Month 12
Number of treatment related toxicities
Time frame: Up to 12 months after completion of treatment
Progression free survival
Time frame: Month 12
Distant metastasis-free survival
Time frame: Month 12
Overall survival
Time frame: Month 12
Number of doses that were planned and delivered
Time frame: Up to 3 months
Number of normal tissue true delivered doses with grade 3+ toxicity at 12 months after completion of MRgRT
Time frame: 12 months after completion of treatment
Rate of cases in which the prescribed isodose line failed to cover 95% of the gross tumor volume (GTV)
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Nicholas.Colangelo@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Related trials for Primary Renal Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 4
Autonomic and Renal Contributions to Hypertension With ADT
Androgen Deprivation Therapy, Prostate Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
Active, not recruitingPhase 2
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas Colangelo, MD, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI-guided linear accelerator and Magnetic resonance imaging (MRI)-guided radiation therapy (MRgRT) in people with Primary Renal Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas Colangelo, MD, PhD (212-731-5003, Nicholas.Colangelo@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of grade 2 or higher toxicity events (time frame: Up to 12 months after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.