Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE2
62 participants
INTERVENTIONAL
2025-12-31
2030-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MRI-guided Adaptive Stereotactic Ablative Body Radiotherapy (SABR)
Participants will receive a single fraction of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) using the MRIdian system. Treatment includes daily adaptive planning based on MRI to optimize dose delivery to the tumor and minimize dose to surrounding normal tissue. Eovist contrast is administered before treatment to enhance visualization. Patients perform an inspiratory breath hold during radiation delivery to minimize motion.
MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)
A single fraction of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) will be delivered using the MRIdian system. Treatment includes adaptive planning based on daily MRI imaging to update tumor and organ-at-risk contours and optimize the radiation dose. On the day of treatment, Eovist contrast is administered 20 minutes before therapy to enhance tumor visualization. Patients perform an inspiratory breath hold during radiation delivery to minimize motion. The total dose is 30-40 Gy delivered in one fraction using external beam techniques.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)
A single fraction of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) will be delivered using the MRIdian system. Treatment includes adaptive planning based on daily MRI imaging to update tumor and organ-at-risk contours and optimize the radiation dose. On the day of treatment, Eovist contrast is administered 20 minutes before therapy to enhance tumor visualization. Patients perform an inspiratory breath hold during radiation delivery to minimize motion. The total dose is 30-40 Gy delivered in one fraction using external beam techniques.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ≥ 18 years old at time of study enrollment
* Child-Pugh A status
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
* Life Expectancy \> 6 months
* For women of childbearing potential or who are not postmenopausal (see Appendix F for Definition of Menopausal Status), a negative urine or serum pregnancy test must be done.
* Ability to understand and the willingness to provide written informed consent.
* Patients treated with prior liver-directed therapies with the exception of radioembolization are eligible for this study if they otherwise meet eligibility criteria
Exclusion Criteria
* Cytotoxic chemotherapy or investigational agent within 1 week of SABR
* Prior radiotherapy overlapping with study treatment site
* Female patients who are pregnant
* Contraindication to having an MRI scan or inability to tolerate MRI
* Presence of a pacemaker or other implanted cardiac device
* Direct tumor extension into the stomach, duodenum, small bowel or large bowel
* Patient unable to breath hold \> 15 seconds
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Viewray Inc.
INDUSTRY
Stanford University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford University
Palo Alto, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Eleanor Brown
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB-82587
Identifier Type: -
Identifier Source: org_study_id