Developing Fast Pediatric Imaging

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

Study Overview

• Status: Recruiting
• Conditions: Pediatric Low-grade Gliomas
• Intervention / Treatment: Other: Wave-CAIPI

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kawin Setsompop, PhD; Phone Number: 617-669-6640; Email: kawin@nmr.mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana Farber Cancer Institute
      • Contact: Susan N Chi, MD; Phone Number: 617-632-3000; Email: schi@partners.org
      • Principal Investigator: Susan N Chi, MD
    • Boston, Massachusetts, United States, 02214
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Kawin Setsompop, PhD; Phone Number: 617-669-6640; Email: kawin@nmr.mgh.harvard.edu
      • Principal Investigator: Kawin Setsompop, PhD
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Boston Children Hospital
      • Contact: Susan N Chi, MD; Phone Number: 617-632-3000; Email: schi@partners.org
      • Principal Investigator: Susan N Chi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary Testing Group; 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	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
Experimental: Software Testing Group; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Dana-Farber Cancer Institute; National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Investigators: Principal Investigator: Kawin Setsompop, PhD, Boston Children Hospital/ Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Neuro Oncology
• Other Study ID Numbers: 18-325; R01EB020613 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor- Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• IPD Sharing Access Criteria: Requests may be directed to: [contact information for Sponsor- Investigator or designee].
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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