Recruiting

Pediatric Imaging

Sponsor:

Boston Children's Hospital

Code:

NCT03761121

Conditions

Pediatric Low-grade Gliomas

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Wave-CAIPI

Study Details

Brief summary:

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

Conditions

Pediatric Low-grade Gliomas

Study ID

NCT03761121

Start date

Apr 15, 2019

Status verified date

Dec, 2025

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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

Interventions

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

Primary outcome measure

  • Wave-CAIPI validation [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Kawin Setsompop, PhD

617-669-6640kawin@nmr.mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02214

Contacts

Kawin Setsompop, PhD

617-669-6640kawin@nmr.mgh.harvard.edu

Principal Investigator:

Kawin Setsompop, PhD

Boston Children Hospital

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Susan N Chi, MD

617-632-3000schi@partners.org

Principal Investigator:

Susan N Chi, MD

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Susan N Chi, MD

617-632-3000schi@partners.org

Principal Investigator:

Susan N Chi, MD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Dec 12, 2025

Last verified

Dec, 2025

Keywords

  • Neuro Oncology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2025-12-12.