Developing Fast Pediatric Imaging

Not Applicable

Recruiting

• Conditions: Pediatric Low-grade Gliomas
• Interventions: Other: Wave-CAIPI

• Registration Number: NCT03761121
• Lead Sponsor: Boston Children's Hospital

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 Timeline

• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-12-03
• Study Start: 2019-04-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2026-09-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary Testing Group	Wave-CAIPI	* This scan is in the same imaging session as the participant's scheduled clinical MRI and is no longer 15 minutes * Wave-CAIPI will be use to enable a 40-60 s acquisition per contrast at 0.9-mm isotropic resolution * Wave-CAIPI will be used to acquire a 4-echo GE-SE time-series at 1.5-mm isotropic resolution
Software Testing Group	Wave-CAIPI	* Participants will receive hour research-only scan * Wave-CAIPI will be use to enable a 40-60 s acquisition per contrast at 0.9-mm isotropic resolution * Wave-CAIPI will be used to acquire a 4-echo GE-SE time-series at 1.5-mm isotropic resolution

Primary Outcome Measures

Name	Time	Method
Wave-CAIPI validation	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.

Trial Locations

Locations (3)

Boston Children Hospital; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States