Developing Fast Pediatric Imaging

Pediatric Low-grade Gliomas Clinical Trial

Official title:

Developing Fast Pediatric Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03761121
• Other study ID #: 18-325
• Secondary ID: R01EB020613
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: March 1, 2025

Study information

• Verified date: June 2023
• Source: Boston Children's Hospital
• Contact: Kawin Setsompop, PhD
• Phone: 617-669-6640
• Email: kawin[@]nmr.mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Low-grade Gliomas

Intervention

Other:
• Wave-CAIPI
"wave-CAIPI" technology, a data acquisition / reconstruction scheme designed to optimally exploit available information in modern multi-channel receivers and in multi-contrast/time-series data for improved image encoding

Locations

Country	Name	City	State
United States	Boston Children Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Children's Hospital	Dana-Farber Cancer Institute, National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wave-CAIPI validation	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.	2 years