Developing Fast Pediatric Imaging
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ClinicalTrials.gov Identifier: NCT03761121 |
Recruitment Status : Unknown
Verified June 2020 by Kawin Setsompop, Dana-Farber Cancer Institute.
Recruitment status was: Recruiting
First Posted : December 3, 2018
Last Update Posted : June 16, 2020
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Condition or disease | Intervention/treatment | Phase |
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Pediatric Low-grade Gliomas | Other: Wave-CAIPI | Not Applicable |
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 (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 |

Arm | Intervention/treatment |
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Experimental: Primary Testing Group
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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
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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 |
- 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.

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.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Contact: Kawin Setsompop, PhD | 617-669-6640 | kawin@nmr.mgh.harvard.edu |
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 |
Principal Investigator: | Kawin Setsompop, PhD | Boston Children Hospital/ Massachusetts General Hospital |
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]. |
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 |
Neuro Oncology |