CLEVELAND, Jan. 4, 2019 /PRNewswire/ -- ViewRay, Inc.
(Nasdaq: VRAY) announced today the enrollment of the first patient
in the Stereotactic MRI-guided On-table Adaptive Radiation Therapy
(SMART) Trial, a multi-center, prospective clinical trial for
locally advanced or borderline pancreatic cancer. The trial
will explore the clinical benefits of precise, high dose radiation
therapy enabled by MR-guidance combined with daily on-table
adaptation in the treatment of pancreatic cancer.
Retrospective analysis of precise, high-dose MR-guided radiation
therapy delivered using adaptive dose planning has shown promising
results with locally advanced pancreatic cancer, suggesting the
potential for improving overall survival relative to patients
receiving lower radiation doses, without increasing the rate of
serious gastrointestinal toxicity. The compelling nature of
the retrospective data prompted the SMART trial, aimed at
investigating in a controlled, prospective manner, the robustness
of this outcome and tracking quality of life over a 5-year trial
period.
"High-definition MR and daily treatment plan adaptation allow us
to deliver ablative radiation doses safely to pancreatic cancer
patients for the first time ever," said Parag Parikh, M.D., co-PI of the study and
Director of GI Radiation Oncology and MR-Guided Radiation Therapy
at the Henry Ford Cancer Institute in Detroit. "Through the SMART trial, we will
build upon the promising experience from UCLA, Washington
University, Amsterdam UMC, University
of Miami and University of
Wisconsin by further exploring MRIdian's impact on
associated toxicity, local control and patient outcomes in
pancreatic cancer at multiple institutions around the world."
The SMART trial is the first prospective, multi-institutional
study to deliver ablative doses of radiation to pancreatic cancer
patients. It aims to enroll 133 participants with borderline
resectable or inoperable locally advanced pancreatic cancer. In the
single-arm study, participants will receive radiation therapy at a
dose of 50 Gray in 5 fractions (treatment sessions) using ViewRay's
MRIdian. On-table adaptive re-planning will be used when clinically
indicated. In all patients, real-time MRI imaging will be used
throughout treatment delivery to monitor the target location and
control the radiation beam as necessary.
The trial's primary outcome measure is grade 3 or higher
gastrointestinal toxicity in the first 90 days after treatment,
with secondary measures including overall survival at two years,
distant progression-free survival at six months, and changes in
patient-reported quality of life.
"Early evidence on the use of MRIdian to treat locally advanced
pancreatic cancer suggests the potential for significantly
prolonged survival and lower toxicity rates. Through this
rigorously designed study, we hope to further validate the
long-term benefits of treatment on the MRIdian," said Scott Drake, President and Chief Executive
Officer of ViewRay. "We believe MRIdian's unique combination of
real-time visualization, automated beam control, and daily
on-table treatment adaptation has the potential to become the
standard of care in radiation oncology."
Along with Parag Parikh, M.D.
from Henry Ford Cancer Institute, the trial is led by Percy Lee, M.D. from the University of California Los Angeles.
For more information on the SMART trial, please visit
https://clinicaltrials.gov/ct2/show/NCT03621644.
About the SMART Trial
The SMART trial is designed to enroll 133 participants with
borderline resectable or inoperable locally advanced pancreatic
cancer. Patients must be 18 years and older and have documented
non-metastatic disease after 3 months of systemic therapy.
Radiation therapy will be delivered using ViewRay's MRIdian at a
prescribed dose of 50 Gray (Gy) in 5 fractions. Each participant
will be aligned in the treatment system with MRI image-guidance.
On-table adaptive re-planning will be used when clinically
indicated. In all patients, real-time MRI imaging will be used
throughout treatment delivery to monitor the target location and
control the radiation beam as necessary. 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).
About ViewRay®
ViewRay, Inc. (Nasdaq: VRAY), designs, manufactures and markets
the MRIdian® radiation therapy system. MRIdian is built upon a
proprietary high-definition MR imaging system designed from the
ground up to address the unique challenges and clinical workflow
for advanced radiation oncology. Unlike MR systems used in
diagnostic radiology, MRIdian's high-definition MR was purpose
built to address specific challenges, including beam distortion,
skin toxicity, and other concerns that potentially may arise when
high magnetic fields interact with radiation beams. ViewRay and
MRIdian are registered trademarks of ViewRay, Inc.
Intended Use: 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.
Forward Looking Statements: This press release
contains forward-looking statements. Statements in this press
release that are not purely historical are forward-looking
statements. These statements are subject to risks and uncertainties
that could cause future results to differ materially from those
referenced. Forward looking statements include, but are not limited
to references to the recent study results, clinical trial results,
related clinical experience and patient outcomes. Given these
uncertainties, the reader is advised not to place any undue
reliance on any forward-looking statements. Additional risk factors
include, among others, the ability to raise the additional funding
needed to continue to pursue ViewRay's business and product
development plans, the inherent uncertainties associated with
developing new products or technologies, competition in the
industry in which ViewRay operates, government and regulatory
uncertainty, including but not limited to obtaining authorizations
to market and new tariffs and trade restrictions, and overall
market conditions. These forward-looking statements are made as of
the date of this press release, and ViewRay assumes no obligation
to update the forward-looking statements, or to update the reasons
why actual results differ from those projected in the
forward-looking statements, except as required by law. Investors
should consult all of the information set forth herein and should
also refer to the risk factor disclosure set forth in the reports
and other documents ViewRay files with the SEC available at
www.sec.gov.
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SOURCE ViewRay, Inc.