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

NCT03824366 | Completed Results DMC FDA Device

• 1 other identifier: 201901172
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Completion of enrollment (approximately 29 months)

Study Arms (1)

Volumetric MR imaging planning

EXPERIMENTAL

* 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

Device: Volumetric MR imaging; Radiation: Radiation therapy

Interventions

Volumetric MR imaging DEVICE

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

Volumetric MR imaging planning

Radiation therapy RADIATION

-Standard of care

Volumetric MR imaging planning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis; Hemoptysis; Gastrointestinal Hemorrhage; Superior Vena Cava Syndrome; Mediastinal Diseases

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Hemorrhage; Signs and Symptoms, Respiratory; Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Thoracic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Hyun Kim, M.D.
• Organization: Washington University School of Medicine

kim.hyun@wustl.edu

314-362-8502

Study Officials

• Hyun Kim, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: April 23, 2019
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: January 10, 2025
• Results First Posted: January 30, 2023

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Researches must provide a methodologically sound proposal. Proposals should be directed to kim.hyun@wustl.edu. To gain access, data requestors will need to sign a data access agreement and provide proof of appropriate regulatory approvals as necessary.

Locations

US (1)