Clinical Trials

ViewRay believes in the value of clinical studies and supports sponsored and investigator-initiated research studies.

Stereotactic MRI-Guided On-Table Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer

Ongoing Clinical Study
ViewRay has a sponsored study titled “Prospective phase II Study of Stereotactic MR-guided on-table Adaptive Radiation Therapy (SMART) for Patients with Borderline or Inoperable Locally Advanced Pancreatic Cancer”.

High-dose magnetic resonance imaging (MRI) guided hypofractionated radiation therapy delivered using daily adaptive dose planning has been shown in a retrospective study to result in improved overall survival, relative to patients receiving lower radiation doses, in patients with locally advanced pancreatic cancer, without increasing the rate of serious gastrointestinal toxicity.

The goal of the proposed trial is to investigative in a controlled, prospective manner the robustness of this outcome, and to track quality of life over a 5-year trial period.

Eligible Participants
Patients with borderline resectable or inoperable locally advanced pancreatic cancer who are 18 years and older and meet the inclusion and exclusion criteria noted within the study description.

Trial Design
In this single-arm study, participants will receive radiation therapy using integrated magnetic resonance imaging (ViewRay’s MRIdian MR-Guided Radiation Therapy System) at a dose of 50 Gray in 5 fractions (treatment sessions). Fractions will be delivered at least twice per week and with at least 18 hours between treatments. Each participant will be aligned in the treatment system with MRI-guidance. On-table adaptive replanning will be used when clinically indicated. In all patients, real-time MR-imaging will be used throughout treatment delivery to monitor the target location and control the radiation beam, as necessary.

Outcome Measures
The primary outcome measure of the study is grade 3 or higher gastrointestinal toxicity in the first 90 days after treatment. Secondary measures include overall survival at two years, distant progression-free survival at six months, and changes in patient-reported quality of life (pre-treatment to 12 months post-treatment and for longer periods up to five years).

To find more information regarding the SMART study, our multi-center, prospective, single-arm clinical trial for inoperable, locally advanced or borderline resectable pancreatic cancer, please provide your contact information via the form below or follow the link to the clinicaltrials.gov listing https://ClinicalTrials.gov/show/NCT03621644.

Investigator-Initiated Research

In addition to our sponsored study, ViewRay has a robust investigator-initiated research 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. 

Gastrointestinal

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, Denmark, 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.

Gastric:

Preoperative MR-Guided Radiation Therapy in Gastric Cancer, Hyun Kim, MD, Washington University School of Medicine, Saint Louis, MO, United States | Seoul National University College of Medicine, Seoul, Republic of Korea, 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, https://www.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.

Genitourinary

Prostate:

CT-guided Stereotactic Body Radiation Therapy and MRI-guided Stereotactic Body Radiation Therapy for Prostate Cancer, MIRAGE Study, Amar Kishan, MD, UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States, https://ClinicalTrials.gov/show/NCT04384770

This is a randomized trial designed to evaluate the superiority of magnetic resonance imaging (MRI)-guided stereotactic body radiotherapy (SBRT) over standard computed tomography (CT)-guided SBRT for prostate cancer (PCa) with respect to acute physician-scored genitourinary (GU) toxicity. 

Study of PSMA PET/MR Guided Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost (SBRT-SIB) for High-Intermediate and High Risk Prostate Cancer, Josephine Kang M.D., Ph.D. 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.

Stereotactic Intensity Modulated Radiotherapy After Radical Prostatectomy (SCIMITAR) 

Amar Kishan, MD, UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

https://clinicaltrials.gov/ct2/show/NCT03541850

This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with prostate cancer that has not spread to other parts of the body and have undergone surgery. 

THORACIC

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 applying principals of hypofractionation toward the current treatment paradigm of concurrent chemoradiation and consolidation immunotherapy for locally advanced non-small cell lung cancer (NSCLC).

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 fraction accelerated partial breast irradiation as the sole method of radiation therapy for low-risk stage 0 and I breast carcinoma.

HEAD/CNS

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.

COMBINATION THERAPY

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.

OTHER

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

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

CONFIRM: Magnetic Resonance Guided Radiation Therapy, 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.

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 MedicalAffairs@viewray.com for more information.

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