Pediatric Low-grade GliomasNCT03761121
Developing Fast Pediatric Imaging
A study testing Wave-CAIPI in people with Pediatric Low-grade Gliomas, run by Boston Children's Hospital at 3 sites in United States.
Trial summary
This research study is evaluating the investigational software for magnetic resonance imaging (MRI) systems and techniques to process magnetic resonance (MR) images Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric Low-grade Gliomas
- What is being tested?
- Wave-CAIPI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Apr 2019to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02214
Kawin Setsompop, PhD, 617-669-6640, kawin@nmr.mgh.harvard.edu
Kawin Setsompop, PhD
- Recruiting
Boston Children Hospital
Boston, Massachusetts, 02215
Susan N Chi, MD, 617-632-3000, schi@partners.org
Susan N Chi, MD
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Susan N Chi, MD, 617-632-3000, schi@partners.org
Susan N Chi, MD
About this study
This research study is evaluating the investigational software for magnetic resonance imaging (MRI) systems and techniques to process magnetic resonance (MR) images
Read the 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.
- Conditions
- Pediatric Low-grade Gliomas
- Being tested
- Wave-CAIPI
- Keywords
- Neuro Oncology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wave-CAIPIOther
"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
| Study group | Role | What they receive |
|---|---|---|
| Primary Testing Group | Experimental | * 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 Receives: Other: Wave-CAIPI |
| Software Testing Group | Experimental | * 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 Receives: Other: Wave-CAIPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start15 Apr 2019
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Low-grade GliomasStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Ellen Grant, Boston Children's Hospital
- Investigators
- Kawin Setsompop, PhD, Principal investigator, Boston Children Hospital/ Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761121
- Sponsor's protocol ID
- 18-325
- Other IDs
- R01EB020613
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2018
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Fast Pediatric Imaging
- ClinicalTrials.gov ID
- NCT03761121
- Acronym / sponsor ID
- 18-325
- Conditions
- Pediatric Low-grade Gliomas
- Keywords
- Neuro Oncology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), Dana-Farber Cancer Institute
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is evaluating the investigational software for magnetic resonance imaging (MRI) systems and techniques to process magnetic resonance (MR) images
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Testing Group | Experimental | Other: Wave-CAIPI* 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 |
| Software Testing Group | Experimental | Other: Wave-CAIPI* 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 |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Primary Testing Group, Software Testing Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kawin Setsompop, PhD principal investigator
Boston Children Hospital/ Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wave-CAIPI in people with Pediatric Low-grade Gliomas, run by Boston Children's Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kawin Setsompop, PhD (617-669-6640, kawin@nmr.mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wave-CAIPI validation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.