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

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.

Study Overview

• Status: Terminated
• Conditions: Tumor, Solid
• Intervention / Treatment: Device: 4D Planar US Transducer

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • University of Wisconsin, Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers will be recruited from the general population. Patients will be recruited from clinics that serve this patient population.

Description

Inclusion Criteria (Healthy Volunteers):

• Must be eighteen (18) years of age or older.
• Must be able to provide informed consent.

Inclusion Criteria (Patients):

• Patients diagnosed with malignancies of the liver.

Exclusion Criteria (All):

• Under the age of eighteen (18) years.
• BMI exceeds the size of the bore of the MRI scanner.
• Unable or unwilling to provide informed consent.
• Contraindications, as described in the volunteer consent form, to MR or US scanning such as but not limited to accidental or implanted ferrous metal and/or implanted devices whose function can be disturbed by the main magnetic field, gradient magnetic fields, or radiofrequency energy.
• Women who are pregnant, suspect they might be pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group; Healthy volunteers will be asked to complete a single imaging session that will include acquiring simultaneous 4D ultrasound and 4D MRI scan. A substudy including patients undergoing radiotherapy for malignancies of the abdomen and pelvis. They will also be asked to complete a single imaging session that will include acquiring simultaneous 4D ultrasound and 4D MRI scan.	Device: 4D Planar US Transducer; This 4D planar US transducer is being developed and validated to provide a novel image-guidance technique to directly track tumor motion 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.; Other Names: 4D US
Patient Group; Patients receiving radiotherapy for malignancies of the abdomen and pelvis will be asked to complete two research visits lasting approximately one hour. Each visit will include a 30 minute combined 4D ultrasound and 4D MRI scan.	Device: 4D Planar US Transducer; This 4D planar US transducer is being developed and validated to provide a novel image-guidance technique to directly track tumor motion 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.; Other Names: 4D US

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility testing	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.	12 Months
MR/US Motion Management Platform	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.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of image-guidance technique	The accuracy of our image-guidance technique will be done by showing that several salient features identified in the US scan can be used to predict/model target motion identified in the MR scan. In this context the target will be a large easily identifiable structure in the test subject (e.g. cyst, vessel). MRI and ultrasound images will be acquired simultaneously such that the motion of tissues or organs in the body can be effectively tracked as a function of respiratory state in the subject. In this manner, the ultrasound system will allow real-time tracking of salient features in the patient that are indicative of the respiratory state.	12 Months
Test/re-test	A secondary objective of this substudy is to evaluate the accuracy of probe re-position during subsequent treatment sessions (i.e. test/re-test) in cancer patient subjects. The probe will be positioned during one of the patient subjects and images will be acquired. During a subsequent treatment session the probe will be re-positioned and images will be acquired. The image data will be used to evaluate to measure the concordance between the two datasets.	12 Months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Bryan Bednarz, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2017
• Primary Completion (Actual): October 4, 2019
• Study Completion (Actual): October 4, 2019

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Radiotherapy
• Other Study ID Numbers: 2017-0684; R01CA190298-01A1 (U.S. NIH Grant/Contract); A534800 (Other Identifier: UW Madison); SMPH\MEDICAL PHYSICS (Other Identifier: UW Madison); Protocol Version 5/27/2021 (Other Identifier: UW Madison)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No