Wave-CAIPI for Low Grade Glioma

Recruiting at 2 trial locations

Overseen By Kawin Setsompop, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Pacemakers, Implants, Pregnancy, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Wave-CAIPI for Low Grade Glioma?

Wave-CAIPI has been shown to speed up MRI scans while maintaining image quality for diagnosing brain conditions like enhancing intracranial lesions and brain metastases, which suggests it could be effective for imaging low grade gliomas as well. ^{1 2 3 4 5}

Is Wave-CAIPI safe for use in humans?

Wave-CAIPI has been used in various MRI studies, including those involving children, without specific safety concerns reported. It is primarily a technique to speed up MRI scans and improve image quality, and studies have shown it to be effective without introducing significant artifacts or issues. ^{2 4 6 7 8}

How is the Wave-CAIPI treatment different from other treatments for low grade glioma?

Wave-CAIPI is unique because it uses advanced imaging techniques to speed up MRI scans, allowing for faster and potentially more accurate diagnosis of brain lesions compared to traditional methods. This approach focuses on improving the imaging process rather than directly treating the tumor itself. ^{1 5 6 9 10}

Research Team

Kawin Setsompop, PhD

Principal Investigator

Boston Children Hospital/ Massachusetts General Hospital

Eligibility Criteria

This trial is for infants, children, and adults diagnosed with Low Grade Glioma (LGG), as well as healthy volunteers of any age. Participants must be receiving treatment at DFCI to qualify.

Inclusion Criteria

I am a healthy volunteer of any age.

I have been diagnosed with Low Grade Glioma.

I have low-grade glioma and am being treated at DFCI.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Session

Participants undergo MRI scans using investigational software and techniques to improve image quality

1 session

1 visit (in-person)

Software Testing

Participants receive an hour-long research-only scan to test the investigational software

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness of the imaging techniques

2 years

Treatment Details

Interventions

• Wave-CAIPI

Trial Overview The study is testing a new software called Wave-CAIPI designed to improve MRI systems and the processing of MR images. It aims to develop faster imaging techniques specifically for pediatric use.

Participant Groups

Group I: Software Testing Group Experimental Treatment 1 Intervention

* 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

Group II: Primary Testing Group Experimental Treatment 1 Intervention

* 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

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Findings from Research

Wave-CAIPI MPRAGE demonstrated excellent diagnostic performance for detecting and diagnosing enhancing intracranial lesions, achieving 98.7% agreement for detection and 97.8% for diagnosis compared to conventional MPRAGE, while significantly reducing scan time from 4 minutes 30 seconds to just 2 minutes 39 seconds.

Despite a lower signal-to-noise ratio, Wave-CAIPI MPRAGE maintained comparable contrast-to-noise ratio and provided better motion artifact management, making it a reliable and efficient alternative for intracranial imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wave-controlled aliasing in parallel imaging (Wave-CAIPI): Accelerating speed for the MRI-based diagnosis of enhancing intracranial lesions compared to magnetization-prepared gradient echo. Oh, H., Yim, Y., Chung, MS., et al.[2023]

Wave-CAIPI (Wave-SWI) significantly improves the visualization of brain pathology and overall image quality compared to the standard 2D T2*-weighted Gradient-Echo (T2*w-GRE) sequence in a study of 172 patients undergoing 1.5 T MRI, with all comparisons showing p < 0.001.

Wave-SWI is non-inferior to conventional 3D susceptibility-weighted imaging (SWI) for key diagnostic aspects, while also reducing acquisition time to 70% of that required for T2*w-GRE, making it a promising option for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical validation of Wave-CAIPI susceptibility-weighted imaging for routine brain MRI at 1.5 T. Conklin, J., Figueiro Longo, MG., Tabari, A., et al.[2022]

The CAIPIRINHA VIBE MRI technique significantly improves image quality and sharpness of intrahepatic veins compared to the standard VIBE approach, as shown by higher mean scores from radiologists.

This technique also enhances inter-observer agreement and diagnostic confidence when assessing focal liver lesions, indicating it may be a more reliable method for evaluating liver malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-individual comparison of CAIPIRINHA VIBE technique with conventional VIBE sequences in contrast-enhanced MRI of focal liver lesions. Albrecht, MH., Bodelle, B., Varga-Szemes, A., et al.[2019]

Wave-CAIPI SWI significantly reduces MRI scan times by 78% and 67% compared to standard SWI, allowing for quicker imaging of children without the need for anesthesia.

Despite a slight increase in image noise in the central brain, Wave-CAIPI SWI maintains comparable visualization of normal anatomy and pathology to standard SWI, making it a viable option for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of highly accelerated wave controlled aliasing in parallel imaging (Wave-CAIPI) susceptibility-weighted imaging in the non-sedated pediatric setting: a pilot study. Conklin, J., Tabari, A., Longo, MGF., et al.[2022]

Postcontrast wave-T1-SPACE offers a significant reduction in scan time while maintaining comparable diagnostic performance for larger brain metastases (greater than 5 mm) when compared to the standard high-resolution T1-SPACE sequence.

However, wave-T1-SPACE tends to underestimate smaller enhancing lesions (less than 5 mm) and provides lower overall image quality, suggesting that caution is needed when interpreting results from this sequence for brain metastasis evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of Wave-CAIPI for Postcontrast 3D T1-SPACE in the Evaluation of Brain Metastases. Baek, HJ., Heo, YJ., Kim, D., et al.[2023]

The wave-CAIPI technique allows for highly accelerated 3D imaging with minimal artifacts and low g-factor penalties, achieving full-brain gradient echo acquisition at a high resolution of 1 mm isotropic voxel size and an acceleration factor of 9.

Compared to other advanced imaging techniques, wave-CAIPI significantly reduces maximum g-factors, making it a promising method for clinical applications in high-resolution volumetric imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wave-CAIPI for highly accelerated 3D imaging. Bilgic, B., Gagoski, BA., Cauley, SF., et al.[2022]

The new 3D Wave-bSSFP imaging technique significantly reduces banding artifacts while maintaining high acceleration performance, achieving up to 12× faster imaging at 0.8 mm isotropic resolution in brain scans.

Wave-bSSFP outperforms the existing CAIPIRINHA technique in both visual and quantitative assessments, demonstrating its potential for clinical applications in fast and high-quality imaging of the brain, spine, and abdomen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated 3D bSSFP Using a Modified Wave-CAIPI Technique With Truncated Wave Gradients. Su, S., Qiu, Z., Luo, C., et al.[2021]

The Wave-controlled aliasing in parallel imaging (Wave-CAIPI) post-contrast 3D T1 SPACE sequence is as effective as the standard high-resolution sequence for detecting brain metastases, with a significant reduction in scan time (three times faster).

Both sequences provided equivalent diagnostic quality and visualization of enhancing lesions, with Wave-CAIPI showing only slightly higher background noise, indicating it is a viable alternative for faster MRI examinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Post-contrast Wave-CAIPI T1 SPACE Achieves Equivalent Diagnostic Performance Compared With Standard T1 SPACE for the Detection of Brain Metastases in Clinical 3T MRI. Goncalves Filho, ALM., Conklin, J., Longo, MGF., et al.[2020]

In a study involving 64 patients undergoing liver MRI, the CAIPIRINHA technique significantly improved image quality, showing better clarity of hepatic vessels and lesion visibility compared to the standard parallel acquisition technique.

Despite some increased artifacts with CAIPIRINHA, it provided higher spatial resolution and overall better image quality in T1-weighted imaging, making it a promising option for liver imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical application of controlled aliasing in parallel imaging results in a higher acceleration (CAIPIRINHA)-volumetric interpolated breathhold (VIBE) sequence for gadoxetic acid-enhanced liver MR imaging. Yu, MH., Lee, JM., Yoon, JH., et al.[2022]

The CAIPIRINHA concept enhances parallel imaging by modifying aliasing artifacts during data acquisition, leading to improved reconstruction in both 2D and 3D imaging.

In 2D CAIPIRINHA, aliasing is controlled through a modified phase encoding sampling strategy, allowing for more efficient use of coil sensitivity variations, which results in a more robust imaging process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled aliasing in volumetric parallel imaging (2D CAIPIRINHA). Breuer, FA., Blaimer, M., Mueller, MF., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Wave-controlled aliasing in parallel imaging (Wave-CAIPI): Accelerating speed for the MRI-based diagnosis of enhancing intracranial lesions compared to magnetization-prepared gradient echo. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Clinical validation of Wave-CAIPI susceptibility-weighted imaging for routine brain MRI at 1.5 T. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Intra-individual comparison of CAIPIRINHA VIBE technique with conventional VIBE sequences in contrast-enhanced MRI of focal liver lesions. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of highly accelerated wave controlled aliasing in parallel imaging (Wave-CAIPI) susceptibility-weighted imaging in the non-sedated pediatric setting: a pilot study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Usefulness of Wave-CAIPI for Postcontrast 3D T1-SPACE in the Evaluation of Brain Metastases. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Wave-CAIPI for highly accelerated 3D imaging. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Accelerated 3D bSSFP Using a Modified Wave-CAIPI Technique With Truncated Wave Gradients. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Accelerated Post-contrast Wave-CAIPI T1 SPACE Achieves Equivalent Diagnostic Performance Compared With Standard T1 SPACE for the Detection of Brain Metastases in Clinical 3T MRI. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Clinical application of controlled aliasing in parallel imaging results in a higher acceleration (CAIPIRINHA)-volumetric interpolated breathhold (VIBE) sequence for gadoxetic acid-enhanced liver MR imaging. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Controlled aliasing in volumetric parallel imaging (2D CAIPIRINHA). [2022]