Imaging and Plan Workflow in a Novel Low-Field Magnetic Resonance Imaging (MRI) Radiotherapy Device

NCT02331381 | Terminated Phase 1 DMC FDA Device

• 1 other identifier: 201311081
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The results of this imaging and treatment planning protocol will aid in developing procedures for patient localization and future clinical implementation of low-field MRI to confirm positioning prior to radiation treatment. Images acquired during this study may aid future study design for adaptive planning based on low-field MRI images. Moreover, results of this imaging and treatment planning may lead to guidance on optimal use of this novel device.

Conditions

Cancer; Malignant Tumor

Outcome Measures

Primary Outcomes (2)

• Adequacy of the radiation therapy plan

  The radiation plan will be evaluated based on the recorded clinical goals prescribed by the attending physician. Plans will be classified as 'adequate' if they meet the prescribed goals for the clinical radiation therapy plan.

  Duration of radiation therapy

• Feasibility of patient localization workflow

  The localization time will be classified as 'adequate' if it is less than or equal to 15 minutes.

  Duration of radiation therapy

Study Arms (1)

MRI

EXPERIMENTAL

Participants will have a custom immobilization device created for them for the purpose of the study. They will be scanned from one to four occasions during radiation treatment. If enrolled in the study prior to the first radiation treatment, the first imaging scan may be scheduled prior to the first radiation treatment, with subsequent scans during treatment separated by at least one day. Patients will be in the scanner for approximately 30 minutes to one hour, either prior to or following their standard of care radiotherapy treatment.

Device: Magnetic resonance imaging

Interventions

Magnetic resonance imaging DEVICE

Also known as: MRI

MRI

Eligibility Criteria

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

Eligibility Criteria: * Scheduled to receive radiation therapy. * At least 18 years of age. * Does not meet any standard contraindications for MRI (such as being claustrophobic, having metal objects within the body that cannot be removed or having large tattoos), confirmed by completion of our clinical MRI questionnaire form * Able to understand and willing to sign an IRB approved written informed consent document.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

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

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jeff Michalski, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2015
• First Posted: January 6, 2015
• Study Start: December 26, 2013
• Primary Completion: December 23, 2015
• Study Completion: September 7, 2016
• Last Updated: February 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)