Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Developing Fast Pediatric Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03761121
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Kawin Setsompop, Dana-Farber Cancer Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This research study is evaluating the investigational software for magnetic resonance imaging (MRI) systems and techniques to process magnetic resonance (MR) images

Condition or disease Intervention/treatment Phase
Pediatric Low-grade Gliomas Other: Wave-CAIPI Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Developing Fast Pediatric Imaging
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761121


Contacts
Layout table for location contacts
Contact: Kawin Setsompop, PhD 617-669-6640 kawin@nmr.mgh.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02214
Contact: Kawin Setsompop, PhD    617-669-6640    kawin@nmr.mgh.harvard.edu   
Principal Investigator: Kawin Setsompop, PhD         
Boston Children Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Susan N Chi, MD    617-632-3000    schi@partners.org   
Principal Investigator: Susan N Chi, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Susan N Chi, MD    617-632-3000    schi@partners.org   
Principal Investigator: Susan N Chi, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
Layout table for investigator information
Principal Investigator: Kawin Setsompop, PhD Boston Children Hospital/ Massachusetts General Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Kawin Setsompop, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03761121    
Other Study ID Numbers: 18-325
R01EB020613 ( U.S. NIH Grant/Contract )
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data can be shared no earlier than 1 year following the date of publication.
Access Criteria: Requests may be directed to: [contact information for Sponsor- Investigator or designee].

Layout table for additional information
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
Keywords provided by Kawin Setsompop, Dana-Farber Cancer Institute:
Neuro Oncology