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Clinical Trials/NCT03761121
NCT03761121
Recruiting
Not Applicable

Developing Fast Pediatric Imaging

Boston Children's Hospital3 sites in 1 country300 target enrollmentStarted: April 15, 2019Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
300
Locations
3
Primary Endpoint
Wave-CAIPI validation

Overview

Brief Summary

This research study is evaluating the investigational software for magnetic resonance imaging (MRI) systems and techniques to process magnetic resonance (MR) images

Detailed Description

The purpose of the study is to develop new technologies for MRI systems. The new technologies should improve MRI capabilities in terms of how sensitive, specific, and efficient they are. The overall goal is to get better measurements of the brain tumor tissue(s).

In this research study, the investigators want to learn more about investigational software and about techniques to process MR images. The testing of investigational software will allow the investigators to improve the image quality. As part of the testing process, the investigators will collect more MR images of the brain, and improve current image reconstruction methods. This will allow a more precise analysis of MR images and potentially better assessment of the brain tumor tissue volume.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (Investigator)

Eligibility Criteria

Ages
0 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Infants, children and adults who have been diagnosed with Low Grade Glioma
  • Healthy volunteers - Children from age 0 to adults with no upper age limit or;
  • Diagnosed with LGG and being treated at DFCI;

Exclusion Criteria

  • Electrical implants such as cardiac pacemakers or perfusion pumps;
  • Ferromagnetic implants such as aneurysm clips, surgical clips, prosthesis, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants;
  • Ferromagnetic objects such as jewelry or metal clips;
  • Women of childbearing age who are seeking to become pregnant, who are breastfeeding, or who suspect they may be pregnant;
  • Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions;
  • Any greater than normal potential for cardiac arrest

Outcomes

Primary Outcomes

Wave-CAIPI validation

Time Frame: 2 years

The outcome measure for this project will be that the rapid scan from Wave-CAIPI can provide equivalent diagnostic quality to that of standard clinical acquisitions which is performed at much slower speed. This will be assess using visual qualitative assessment by experienced radiologists on the project.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ellen Grant

Principal Investigator

Boston Children's Hospital

Study Sites (3)

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