MRIdian SMART: Treat and Prove What Others Can’t

At ViewRay, we believe in the value of clinical studies, support sponsored, and investigator-initiated research studies defined.

Definition of Clinical Success

5 or Fewer
Fractions

Ablative
Doses

Tight
Margins

No Implants Required

No or Low Grade 3 Toxicity

Ongoing Clinical Research

In addition to our sponsored study, ViewRay has a robust investigator-initiated research (IIR) program supporting clinical and technical projects. For more information, please visit our IIR page. Additionally, please see the list of publicly referenced clinical, prospective, phase I, II, or III studies below.

Pancreas:

Stereotactic Body Radiotherapy and Focal Adhesion Kinase Inhibitor in Advanced Pancreas Adenocarcinoma, Hyun Kim, MD, Washington University School of Medicine, Saint Louis, Missouri, United States, https://ClinicalTrials.gov/show/NCT04331041

Patients with advanced pancreas adenocarcinoma will be treated with standard of care chemotherapy followed by stereotactic body radiotherapy (SBRT) concurrent with the focal adhesion kinase (FAK) inhibitor and assessed for clinical outcomes such as progression free survival (PFS), local control, distant control, and toxicity in this study. 

Nivolumab, Ipilimumab and Chemoradiation in Treating Patients With Locally Advanced Pancreatic Cancer (LAPTOP), Inna Chen, MD, Herlev & Gentofte University Hospital, Herlev, Denmark, https://ClinicalTrials.gov/show/NCT04247165

This study is to explore the safety and synergy of the proposed combinatorial approach, participants with locally advanced PC will receive nivolumab and ipilimumab administered in combination with gemcitabine and nab-paclitaxel followed by immune-chemoradiation.

Stereotactic Radiotherapy vs Best Supportive Care in Unfit Pancreatic Cancer Patients (PANCOSAR), Anna Bruynzeel, MD, PhD, Amsterdam UMC, Amsterdam, Netherlands, https://ClinicalTrials.gov/ct2/show/NCT05265663

This multicenter randomized controlled trial is to investigate the potential benefit in survival and quality of life after SABR in patients with localized PDAC for whom no other treatment is available, as compared to controls managed with best supportive care.

MR-Guided Adaptive Stereotactic Body Radiotherapy (SBRT) of Primary Tumor for Pain Control in Metastatic Pancreatic Ductal Adenocarcinoma (MASPAC), Maximilian Niyazi, MD, MSc, University of Munich, Munich, Bavaria, Germany, https://ClinicalTrials.gov/ct2/show/NCT05114213

The MASPAC trial investigates the added benefit of MR-guided adaptive SBRT of the primary tumor embedded between standard chemotherapy cycles for pain control and prevention of pain in patients with metastatic PDAC (mPDAC).

Gastric:

Preoperative MR-Guided Radiation Therapy in Gastric Cancer, Hyun Kim, MD, Washington University School of Medicine, Saint Louis, Missouri, United States, https://ClinicalTrials.gov/show/NCT04162665

Patients with locoregional gastric adenocarcinoma will receive hypofractionated magnetic resonance guided radiotherapy followed by chemotherapy followed by surgery and pathologic complete response (pCR) rate will be quantified in this study.

Liver:

Adaptative MR-Guided Stereotactic Body Radiotherapy of Liver Tumors (RASTAF), Magali Rouffiac Thouant, MD, & Emlie Rederstorff, PhD, Centre Georges François Leclerc, Dijon, France, https://ClinicalTrials.gov/show/NCT04242342

This is a phase II adaptative magnetic resonance-guided stereotactic body radiotherapy (SBRT) study for treatment of primary or secondary progressive liver tumors.

OAR-Based, Dose Escalated SBRT with Real Time Adaptive MRI Guidance for Liver Metastases, Michael Bassetti, MD, PhD, University of Wisconsin, Madison, Wisconsin, United States, https://ClinicalTrials.gov/ct2/show/NCT04020276

This trial is to identify a safe maximum tolerated dose level for magnetic resonance image (MRI)-guided stereotactic body radiotherapy (SBRT) treatment of bowel and liver metastases, respectively.

Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases (MAESTRO), Jürrgen Debus, MD, PhD, University Hospital Heidelberg, Heidelberg, Germany, https://ClinicalTrials.gov/ct2/show/NCT05027711

The MAESTRO trial aims to assess the potential advantages of adaptive, gated MR-guided SBRT (MRgSBRT) compared to conventional SBRT at a standard linac using an ITV (internal target volume) approach (ITV-SBRT), in patients with liver metastases.

Rectum:

THeragnostic Utilities for Neoplastic DisEases of the Rectum by MRI Guided Radiotherapy (THUNDER2), Giuditta Chiloiro, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy, https://ClinicalTrials.gov/ct2/show/NCT04815694

This trial is to investigate the impact of dose escalation in rectal cancer, identifying the poor responder cases using the ERI index during the course of radiotherapy and increasing the prescribed dose in these patients.

Adaptive Radiation for Locally Advanced Rectal Adenocarcinoma, Jessica M Frakes, MD & Seth Felder, MD, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States, https://ClinicalTrials.gov/ct2/show/NCT05108428

The purpose of this study is to determine the feasibility of using magnetic resonance imaging (MRI)-guided adaptive chemoradiation therapy to improve response to treatment, in patients with locally advanced rectal adenocarcinoma.

Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems (DWI_RECT_MRGRT), Marguerite TYRAN, MD, Institut Paoli Calmettes, Marseille, Bouches Du Rhone, France, https://ClinicalTrials.gov/ct2/show/NCT03961776

This trial is to demonstrate feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.

Prostate:

Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer With Rising PSA After Radical Prostatectomy (EXCALIBUR), Amar Kishan, MD, UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States, https://ClinicalTrials.gov/ct2/show/NCT04915508

This phase II trial investigates the effect of extremely hypofractionated intensity-modulated stereotactic body radiotherapy in treating patients with prostate cancer that has rising prostate-specific antigen (PSA) after radical prostatectomy.

Study of PSMA PET/MR Guided Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost (SBRT-SIB) for High-Intermediate and High Risk Prostate Cancer, Ariel Marciscano, MD, Weill Cornell Medicine, New York, New York, United States, https://ClinicalTrials.gov/show/NCT04402151

Patients will undergo prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET)/Magnetic Resonance (MR) prior to start of the radiation treatment planning process and will be evaluated for recurrence free survival in this study.

Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer in 4 Weeks v. 2 Weeks (SHORTER) Himanshu Nagar, MD, Weill Cornell Medicine, New York, New York, United States, https://ClinicalTrials.gov/ct2/show/NCT04422132

This study will compare urinary and bowel side effects of hypofractionated radiotherapy in 20 treatments (4 weeks) to ultra-hypofractionated radiotherapy in 5 treatments (2 weeks) for prostate cancer that has returned after prostatectomy and evaluate time to progression and the quality of life.

Randomized Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer (FORT), Himanshu Nagar, MD, Weill Medical College of Cornell University, New York, New York, United States, https://ClinicalTrials.gov/ct2/show/NCT04984343

This randomized phase II study is to compare 5 radiation therapy treatments to 2 radiation therapy treatments in men with low or intermediate-risk prostate cancer.

Feasibility Study of Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE), Timothy McClure, MD, Weill Medical College of Cornell University, New York, New York, United States, https://ClinicalTrials.gov/ct2/show/NCT05345444

This is a single-site feasibility trial with favorable intermediate risk prostate cancer who undergo Irreversible Electroporation (IRE) followed by Magnetic Resonance guided Radiotherapy MRgRT. The investigators hypothesize that the combined therapy will feasible and be safe to perform with low morbidity.

PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer, Ariel Marciscano, MD, Weill Medical College of Cornell University, New York, New York, United States, https://ClinicalTrials.gov/ct2/show/NCT04220983

This trial is to demonstrate the safety and feasibility of using 36.25 Gy in 5 fractions, plus a simultaneous integrated boost (when indicated), in patients with metastatic prostate cancer.

Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer (SMILE), Stefan Körber, MD, University Hospital Heidelberg, Heidelberg, Germany, https://ClinicalTrials.gov/ct2/show/NCT04845503

This prospective, non-randomized, multicentric, Phase II SMILE study is to test whether the MRI-guided radiotherapy with a greatly shortened radiotherapy of the prostate over 5 radiation sessions is possible and safe.

MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days (Proseven), Mark De Ridder, MD, Universitair Ziekenhuis Brussel, Brussels, Belgium, https://ClinicalTrials.gov/ct2/show/NCT04896801

The Proseven trial is a prospective interventional study that will evaluate the toxicity and efficacy of MR-guided stereotactic body radiotherapy (SBRT) in the profound hypofractionated treatment of prostate cancer. Patients will be treated in 5 daily fractions within a short overall treatment time (OTT) of 7 days.

Lung:

Magnetic Resonance-Guided Hypofractionated Adaptive Radiation Therapy With Concurrent Chemotherapy and Consolidation Durvalumab for Inoperable State IIB and IIIA Non-small Cell Lung Cancer, Gregory Vlacich, MD, PhD, Washington University School of Medicine, St. Louis, Missouri, United States, https://ClinicalTrials.gov/ct2/show/NCT03916419

This prospective, single-arm, phase II clinical trial with safety lead-in will test the feasibility and outcomes of magnetic resonance (MR)-guided radiation therapy system and apply principles of hypofractionation toward the current treatment paradigm of concurrent chemoradiation and consolidation immunotherapy for locally advanced non-small-cell lung cancer (NSCLC).

Magnetic Resonance Guided Adaptive Stereotactic Body Radiotherapy for Lung Tumors in Ultracentral Location (MAGELLAN), Juliane Hörner-Rieber, MD, University Hospital of Heidelberg, Heidelberg, Germany, https://ClinicalTrials.gov/ct2/show/NCT04925583

MAGELLAN is a phase-I dose escalation trial that aims to identify the maximum tolerated dose (MTD) of MR-guided SBRT of ultracentral lung Tumors (primary objective).

Study of LUNG Stereotactic Adaptive Ablative Radiotherapy (LUNG STAAR), Rupesh Kotecha, MD, Miami Cancer Institute, Miami, Florida, United States, https://ClinicalTrials.gov/ct2/show/NCT04917224

The proposed study expands on the principles of SBRT (Stereotactic Body Radiation Therapy) and SABR (Stereotactic Ablative Radiotherapy) for centrally located NSCLC (Non-Small Cell Lung Cancer) to further optimize outcomes in this patient population with utilization of the adaptive workflow to maintain tumor control rates but decrease the incidence and grade of treatment-related toxicities.

A Multicenter Phase II Study of Stereotactic Radiotherapy for Centrally Located Lung Tumors (STRICT-LUNG STUDY) and Ultra-centrally Located Lung Tumors (STAR-LUNG STUDY). (STRICTSTARLUNG), Mette Pøhl, MD, PhD, Rigshospitalet, Copenhagen, Denmark, https://ClinicalTrials.gov/ct2/show/NCT05354596

An open-label phase II study, investigating toxicity, treatment efficacy and the local tumor control rate in 69 patients with centrally located tumors and in 69 patients with ultra-centrally located tumors in the lung. Ultra-centrally tumors are treated on MR-linacs with daily MR-guided plan-adaptation.

Nano-SMART: Nanoparticles With MR Guided SBRT in Centrally Located Lung Tumors and Pancreatic Cancer, Jonathan Leeman, MD, Brigham and Women's Hospital, Boston, Massachusetts, United States, https://ClinicalTrials.gov/ct2/show/NCT04789486

This research study is being done to help determine the safety and efficacy of gadolinium based nanoparticle, Activation and Guidance of Irradiation X (AGuIX), used in conjunction with MR-guided stereotactic body radiation therapy (SBRT) in the treatment of pancreatic cancer and lung tumors.

Breast: 

Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer, Bethany Anderson, MD, University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States, https://ClinicalTrials.gov/show/NCT03936478

This trial will investigate a novel 3-fraction radiation regimen for participants undergoing breast-conserving therapy (BCT) for early breast cancer. 

Three Fraction Accelerated Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-risk Stage 0 and I Breast Carcinoma, Imran Zoberi, MD, & William Kennedy, MD, Washington University School of Medicine, Saint Louis, Missouri, United States, https://ClinicalTrials.gov/show/NCT03612648

This single institution, phase I/II study is designed primarily to evaluate three fractions accelerated partial breast irradiation as the sole method of radiation therapy for low-risk stage 0 and I breast carcinoma.

Single Fraction Accelerated Partial Breast Irradiation vs. Five Fraction Accelerated Partial Breast Irradiation for Low-risk Stage 0 and I Breast Carcinoma (BreaStBRT), Imran Zoberi, MD, Washington University School of Medicine, Saint Louis, Missouri, United States, https://ClinicalTrials.gov/ct2/show/NCT04849871

This study will evaluate the local control, complication rates, cosmetic results, and quality of life between patients treated with a single fraction vs. five fractions of accelerated partial breast irradiation (S_APBI vs. F_APBI) when used as the sole method of radiation therapy.

Pilot Study of Same-session MR-only Simulation and Treatment With Stereotactic MRI-guided Adaptive Radiotherapy (SMART) for Oligometastases of the Spine, Lauren Henke, MD, M.S.C.I., Washington University School of Medicine, Saint Louis, Missouri, United States, https://ClinicalTrials.gov/show/NCT03878485

This study will evaluate short-term goals of workflow feasibility and safety of same-session magnetic resonance (MR)-only simulation and treatment planning, on-table, using stereotactic magnetic resonance image (MRI)-guided adaptive radiotherapy (SMART). 

MARTHA-trial: MRI – Guided Adaptive RadioTHerapy for Reducing XerostomiA in Head and Neck Cancer Including Longitudinal Evaluation of the Patient’s Immune Profile Under Radiotherapy, Panagiotis Balermpas, MD, Zurich University Hospital, Zurich, Switzerland, https://ClinicalTrials.gov/show/NCT03972072

This prospective, phase II trial is to evaluate xerostomia after magnetic resonance image (MRI)-guided adaptive radiotherapy of head and neck cancer.

Immune Checkpoint Inhibitor and MR-guided SBRT for Limited Progressive Metastatic Carcinoma, Michael Chuong, MD, Miami Cancer Institute, Miami, FL, United States, https://ClinicalTrials.gov/show/NCT04376502

This is an open-label, single arm, phase II clinical trial in patients with metastatic solid malignancy of any histology who have previously experienced limited progression in at least 1 and up to 5 lesions while on immune checkpoint inhibitors monotherapy.

SMART Master Protocol, Stereotactic Magnetic Resonance Guided Radiation Therapy, Jonathan Leeman, MD, Brigham & Women’s Hospital, Boston, Massachusetts, United States, https://ClinicalTrials.gov/show/NCT04115254

This is a master prospective Phase I-II trial evaluating the feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer.

CONFIRM: Magnetic Resonance Guided Radiation Therapy, Raymond Mak, MD, Brigham & Women’s Hospital, Boston, Massachusetts, United States | Dana Farber Cancer Institute, Boston, Massachusetts, United States, https://ClinicalTrials.gov/show/NCT04368702

This is a master clinical protocol evaluating magnetic resonance (MR) image-guided radiation in patients with gastric and breast cancer.

Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction (SMART ONE), Michael Chuong, MD, Miami Cancer Institute, Miami, Florida, United States, https://ClinicalTrials.gov/ct2/show/NCT04939246

This is a multi-site single arm feasibility study of single-fraction Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) for primary or metastatic carcinoma involving the lung, liver, adrenal gland, abdominal/pelvic lymph node, pancreas, and/or kidney.

SOFT- Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases (SOFT), Mette Felter, MD, Herlev Hospital, Herlev, Denmark, https://www.ClinicalTrials.gov/ct2/show/NCT04407897

This prospective phase II multicenter-study will evaluate the feasibility and safety of MR-guided stereotactic ablative radiotherapy (SABR) for infra-diaphragmatic soft tissue metastases.

Medical Services

The MRIdian Linac System, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. Medical information services provides support for medical, scientific, and technical information in response to inquiries regarding the use of ViewRay products. Contact our Medical Affairs team at [email protected] for more information.

Join a Clinical Study

We appreciate your interest in collaborating with us on your research project. To request an IIR application, please complete the form below.

When you are ready to submit your IIR application, please also include the following supporting documents:

  • Draft protocol or study synopsis
  • Current CV
  • Detailed budget estimate
  • Please send the IIR application and supporting documents to [email protected].

Upon submission, you will receive an email confirmation from the ViewRay Medical Affairs team within 72 hours.

Review Process

After submission, your IIR proposal will be reviewed by a member of the ViewRay Medical Affairs team. During this time, they will provide status updates and may reach out for additional information.

Your submission will then be reviewed by an internal ViewRay committee. This committee meets on a monthly basis. After a determination is made, the applicant will be contacted by the Medical Affairs team.