N/A
N=20
Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy
Malignancy · Metastasis · Hemoptysis · Gastrointestinal Bleeding · Pelvic Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT03824366 ↗Enrolled (actual)
20
Serious AEs
12.5%
Results posted
Jan 2023
Primary outcome: Primary: Feasibility of Same-session MRI-only Simulation as Defined as More Than 70% of Patients Receiving at Least 70% of Their Scheduled Treatment Fractions on the First On-table Attempt for Each Respective Fraction. — 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Volumetric MR imaging (Device); Radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Same-session MRI-only Simulation as Defined as More Than 70% of Patients Receiving at Least 70% of Their Scheduled Treatment Fractions on the First On-table Attempt for Each Respective Fraction. |
16 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03824366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.