ClinicalTrials.gg
RecruitingNCT07767500SMARTERUpdated Aug 21, 2026

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

An interventional study of MRI-guided linear accelerator and Magnetic resonance imaging (MRI)-guided radiation therapy (MRgRT) in Primary Renal Cancer, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 551 studies in Kidney Neoplasms with a site in United States — 67 open to participants now, 109 under way, 4 of them phase 3. Kidney Neoplasms · United States.

Planned enrollment
251st of 443
30 · median 37
Started
2026
with 16 others
No phase
58 of 551
10 open now
Primary completion
2029-10
later than 96 of 103 live
Registered
546th of 551
by date

Among the 551 studies in Kidney Neoplasms with a site in United States, this one is the 251st largest by planned enrollment of the 443 interventional ones that give a count, is one of 17 that started in 2026, is one of 58 with no phase, reaches primary completion later than 96 of the 103 other live ones, and was the 546th registered.

Kidney Neoplasms

969 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

Browse Kidney Neoplasms studies →

Open to participants now

67 of the 551 studies in Kidney Neoplasms with a site in United States are open now. Recruiting first, the newest first:

61 more — sign in →

All 67 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 173 Kidney Neoplasms studies recruiting now, 133 (77%) set no upper age limit and 15 (9%) stop at 75 or younger; 20 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 551 studies in Kidney Neoplasms with a site in United States, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Primary Renal Cancer

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients at or over 18 years old.
  2. 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.
  3. Have a confirmed diagnosis of renal cell carcinoma (RCC) of any histology, or radiographic diagnosis if 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.
  4. 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.

  5. Tumor stage of cT1a-b, cN0, M0 (i.e. less than 7 cm in greatest dimension).
  6. 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.

  7. Have (ECOG) performance status 0-2.
  8. Have of 2 years or more.

Exclusion criteria

Exclusion Criteria:

  1. An MRI (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.
  2. A pre-treatment estimated \< 30 cc/min.
  3. Visceral, nodal, or bony disease.
  4. Is pregnant or expecting to conceive within the projected duration of the trial at the screening visit.
  5. Pregnant or breastfeeding individuals, or individuals of who have a positive pregnancy test at screening or prior to radiation treatment initiation.
  6. Individuals of childbearing potential who are unwilling to use one highly effective method of and one additional effective method of contraception, or abstain from heterosexual intercourse, during study participation and for 6 months after completion of study therapy.
  7. Previous high dose radiation treatment to an overlapping area.
  8. Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy.
  9. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  10. Is on systemic therapy that is reasonably expected to modify radiation sensitivity and cannot be stopped for a sufficient to allow for radiation treatment.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study 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.

    Device: MRI-guided linear accelerator · Radiation: Magnetic resonance imaging (MRI)-guided radiation therapy (MRgRT)

Interventions

  • DeviceMRI-guided linear accelerator

    MRI images are obtained before treatment, for adaptive planning, as well as in real-time, to allow for motion monitoring and respiratory gating.

  • RadiationMagnetic 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. 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.

    Also known as: Elekta Unity MR linac system

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 12 months after completion of treatment

Secondary outcomes

  1. Change in glomerular filtration rate

    Time frame: Baseline, Month 12

  2. Number of treatment related toxicities

    This will provide a broader perspective of toxicity by including the Grade 1 toxicities, relative to the primary endpoint.

    Time frame: Up to 12 months after completion of treatment

  3. Progression free survival

    PFS is defined as the time from initiation of treatment to disease progression or death from any cause.

    Time frame: Month 12

  4. 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.

    Time frame: Month 12

  5. Overall survival

    OS is defined as the time from initiation of treatment to death from any cause.

    Time frame: Month 12

  6. Number of doses that were planned and delivered

    Time frame: Up to 3 months

  7. 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

  8. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

Access criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Nicholas.Colangelo@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Oct 2029, 38 months after the start.

Of 90 non-industry interventional studies with no phase under Kidney Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 94. This study's planned 38 months is below that.

Counting every sponsor, half of 97 studies reached it within 42 months; a quarter within 21 and three quarters within 90.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2026
First posted
Aug 17, 2026
StartActual
Aug 19, 2026
Primary completionEst.
Oct 2029
CompletionEst.
Oct 2030
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07767500
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Aug 17, 2026
Start date
Aug 19, 2026
Primary completion
Oct 2029 (estimated)
Completion
Oct 2030 (estimated)
Last update
Aug 21, 2026

Study contacts

Nicholas Colangelo, MD, PhD
Contact
Nicholas.Colangelo@nyulangone.org
212-731-5003
Nicholas Colangelo, MD, PhD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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