MRIDIAN CLINICAL COMPANY CONTACT LOGIN GLOBAL 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. [ENROLLMENT COMPLETE] 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 GENITOURINARY THORACIC HEAD/CNS COMBINATION THERAPY OTHER 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. 1Chuong MD, Bryant J, Mittauer KE, Hall M, Kotecha R, Alvarez D, Romaguera T, Rubens M, Adamson S, Godley A, Mishra V, Luciani G, Gutierrez AN, Ablative 5-fraction stereotactic magnetic resonance-guided radiation therapy (MRgRT) with on-table adaptive replanning and elective nodal irradiation for inoperable pancreas cancer, Practical Radiation Oncology (2020) 2Finazzi T, Haasbeek CJA, Spoelstra FOB, Palacios MA, Admiraal MA, Bruynzeel AME, Slotman BJ, Lagerwaard FJ, Senan S, Clinical outcomes of stereotactic MR-guided adaptive radiation therapy for high-risk lung tumors International Journal of Radiation Oncology • Biology• Physics (2020); Rosenberg S. A. et al. (2018). A multi-institutional experience of MR-guided liver stereotactic body radiation therapy. Advances in Radiation Oncology, 4(1), 142-149; Rudra S. et al. (2019). Using adaptive magnetic resonance image-guided radiation therapy for treatment of inoperable pancreatic cancer. Cancer Medicine, 8(5), 2123-2132; Henke, L., et al. (2018). Phase I trial of stereotactic MR-guided online adaptive radiation therapy (SMART) for the treatment of oligometastatic or unresectable primary malignancies of the abdomen. Radiotherapy and Oncology, 126(3), 519-526. Henke LE, et al. Stereotactic mr-guided online adaptive radiation therapy (smart) for ultracentral thorax malignancies: Results of a phase 1 trial. Adv Radiat Oncol 2019;4:201-209; Rosenberg SA, et al. A multi-institutional experience of mr-guided liver stereotactic body radiation therapy. Adv Radiat Oncol 2019;4:142-149; Kennedy WR, Thomas MA, Stanley JA, Luo J, Ochoa LL, Clifton KK, Cyr AE, Margenthaler JA, DeWees TA, Price A, Kashani R, Green O, Zoberi I, Single Institution Phase I/II Prospective Clinical Trial of Single Fraction High Gradient Adjuvant Partial Breast Irradiation for Hormone Sensitive Stage 0-I Breast Cancer, International Journal of Radiation Oncology • Biology • Physics (2020); Bruynzeel AME, Tetar SU, Oei SS, Senan S, Haasbeek CJA, Spoelstra FOB, Piet AHM, Meijnen P, Bakker van der Jagt MAB, Fraikin T, Slotman BJ, van Moorselaar RJA, Lagerwaard FJ, A prospective single-arm phase II study of stereotactic magnetic-resonance-guided adaptive radiotherapy for prostate cancer: Early toxicity results, International Journal of Radiation Oncology • Biology • Physics (2019) Home Old Safety Privacy Legal MR-Guided SMART Discover MRIdian MRIdian Locator Medical Affairs Bibliography About ViewRay Newsroom Investors Partner Program Careers Contact ViewRay Headquarters 2 Thermo Fisher Way Oakwood Village, OH 44146 +1 440.703.3210 Phone +1 800.417.3459 Fax West Coast Office 815 E Middlefield Rd Mountain View, CA 94043 +1 650.252.0920 Phone © 2021 VIEWRAY TECHNOLOGIES, INC. 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