Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy

NCT ID: NCT03824366

Last Updated: 2025-01-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-23

Study Completion Date

2022-01-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This proposed study is unique in that patients will not undergo computed tomography (CT) simulation at any point during their treatment course and will instead have same-session magnetic resonance (MR)-only simulation and treatment planning, on-table, using the adaptive radiotherapy (ART) workflow. In this manner, patients requiring urgent treatment could initiate treatment as early as the day of initial radiation oncology consultation.

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.

Malignancy Metastasis Hemoptysis Gastrointestinal Bleeding Pelvic Bleeding Superior Vena Cava Syndrome Mediastinal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Volumetric MR imaging planning

* All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site.
* Patients will receive standard of care palliative radiation therapy

Group Type EXPERIMENTAL

Volumetric MR imaging

Intervention Type DEVICE

This will most frequently be supine with arms positioned so not in the way of treatment beams.

Radiation therapy

Intervention Type RADIATION

-Standard of care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Volumetric MR imaging

This will most frequently be supine with arms positioned so not in the way of treatment beams.

Intervention Type DEVICE

Radiation therapy

-Standard of care

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of malignancy (biopsy proven or high clinical suspicion with urgent/emergent clinical indications for palliative RT)
* Requires delivery of palliative radiation therapy for the treatment of painful metastasis, hemoptysis, gastrointestinal bleeding, pelvic bleeding, or superior vena cava syndrome/bulky mediastinal disease.
* At least 18 years of age.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria

* Pregnant. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.
* Medical contraindication to undergoing MR imaging.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hyun Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201901172

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.