Skip to main content
Clinical Trials/NCT04095091
NCT04095091
Terminated
Not Applicable

Real-time Tumor Localization and Guidance for Radiotherapy Using Ultrasound (US) and Magnetic Resonance (MR)

University of Wisconsin, Madison1 site in 1 country30 target enrollmentSeptember 14, 2017
ConditionsTumor, Solid

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tumor, Solid
Sponsor
University of Wisconsin, Madison
Enrollment
30
Locations
1
Primary Endpoint
Feasibility testing
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

The primary objective of this protocol is to evaluate the feasibility of acquiring simultaneous 4D ultrasound and 4D MRI scans. The imaging performance of the US and MRI scans will be characterized. The secondary objective of this study is to determine if several salient features identified in the US scan can be used to predict target motion identified in the MR scan.

Detailed Description

The goal of radiotherapy treatment of cancer is to cure or locally control the disease while minimizing complications to healthy tissue. Given the complexity of tumor and normal tissue response to radiation, precise and accurate delivery of absorbed dose distributions, within known tolerances, is necessary to achieve the maximum therapeutic ratio. The complex treatment process of radiotherapy introduces geometrical uncertainties including respiratory induced tumor motion. The goal of this research is to develop and validate a novel image-guidance technique to directly track tumor motion using a 4-dimensional (4D) planar ultrasound (US) transducer during radiation therapy that is coupled to a pre-treatment calibration training image set consisting of a simultaneous 4D ultrasound and 4D magnetic resonance imaging (MRI) acquisition. The image sets will be rapidly matched using advanced image and signal processing algorithms, allowing the display of virtual MR images of the tumor/organ motion in real-time from an ultrasound acquisition.

Registry
clinicaltrials.gov
Start Date
September 14, 2017
End Date
October 4, 2019
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Feasibility testing

Time Frame: 12 Months

To conduct non-contrast agent MR and ultrasound scans in order to evaluate and demonstrate, on a continuing basis, the technical and clinical feasibility of new or modified features (the "Prototype") of a combined MRI and ultrasound system, and software. Prototype MRI and ultrasound systems are defined as components of the MRI system (software) and ultrasound system (hardware and software) that have been modified in some form.

MR/US Motion Management Platform

Time Frame: 12 Months

The goal of this trial is to assess the feasibility of implementing the system into clinical practice and to compare the dosimetric advantages of its use. In a retrospective analysis, the patients' standard treatment plan with international target volume (ITV) expansion will be directly compared with a second treatment plan using a smaller respiratory-gated margin (i.e., gross tumor volume (GTV)-only expanded for planning target volume (PTV) without ITV expansion). Normal tissue constraints will be specified and follow standard clinical constraints. The percent of liver volume receiving greater than 18 Gy will be used as a quantitative metric to assess the dosimetric impact of our platform. In addition, overall treatment time with the relative "beam on time" and duty cycle will also be compared. Additionally, the ultrasound acquisition during treatment will be used to assess intra- and interfraction changes in breathing patterns as the patients progress through treatment.

Secondary Outcomes

  • Test/re-test(12 Months)
  • Accuracy of image-guidance technique(12 Months)

Study Sites (1)

Loading locations...

Similar Trials