NCT04095091|TerminatedDMCFDA Device
Study Stopped
Device to be used in study is no longer available
Loading search results
Sponsor study identifier
Secondary identifiers
OTHER · UW Madison
OTHER · UW Madison
OTHER · UW Madison
observational
30
1 country
1
Study Start
September 14, 2017
Actual (reported)Primary Completion
October 4, 2019
Actual (reported)Study Completion
October 4, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 4, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 14, 2017
Actual (reported)September 16, 2019
Actual (reported)September 19, 2019
Actual (reported)October 4, 2019
Actual (reported)October 4, 2019
Actual (reported)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
Accuracy of image-guidance technique
12 Months
Test/re-test
12 Months
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Healthy volunteers will be recruited from the general population. Patients will be recruited from clinics that serve this patient population.
University of Wisconsin, Madison
Madison, Wisconsin, 53704, United States
Bryan Bednarz, PhD
University of Wisconsin, Madison
30 participants (actual enrollment reported by the registry).
First Submitted
September 16, 2019
First Posted
September 19, 2019
Study Start
September 14, 2017
Actual (reported)First-in-Human Study of the SHP2 Inhibitor BBP-398 in Patients With Advanced Solid Tumors
Contact the study team to confirm eligibility.
Primary Completion
October 4, 2019
Actual (reported)Study Completion
October 4, 2019
Actual (reported)Last Updated
October 31, 2023
Record last verified: 2023-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: