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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new MRI software, Wave-CAIPI (Wave-Controlled Aliasing In Parallel Imaging), to enhance brain imaging for individuals with low-grade glioma, a type of brain tumor. The software aims to make MRI scans faster and clearer, potentially helping doctors better understand the condition. The trial includes two groups: one uses the software during regular MRI sessions, and the other undergoes a special research scan. Suitable participants include those diagnosed with low-grade glioma or healthy volunteers without metal implants or devices that could interfere with an MRI. As an unphased trial, this study offers a unique opportunity to advance MRI technology, potentially benefiting future patients.

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 prior data suggests that this investigational software for MRI systems is safe?

Research has shown that Wave-CAIPI, a new software for MRI machines, is safe for people. Studies have found that this software reduces blurriness in images caused by movement, resulting in clearer pictures of small areas. Even if a person moves during an MRI, the images remain clear.

Another study found that Wave-CAIPI produces images similar in quality to standard methods but in less time, reducing the duration patients spend in the MRI machine. Although the images might be slightly less sharp, the benefits of clearer images despite movement and quicker scans are significant.

No reports of harmful effects from using Wave-CAIPI suggest that patients tolerate the software well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Wave-CAIPI for low-grade glioma because it offers a new way to enhance MRI imaging. Unlike standard MRI techniques, which can be time-consuming, Wave-CAIPI enables faster image acquisition, capturing high-resolution images in just 40-60 seconds per contrast. This means that doctors can obtain detailed images with greater efficiency, potentially improving diagnosis and treatment planning. Additionally, this technique allows for a 4-echo GE-SE time-series at different resolutions, providing more comprehensive data than traditional methods.

What evidence suggests that this investigational software is effective for processing MR images in low grade glioma?

Research shows that Wave-CAIPI can enhance MRI scans, particularly for brain imaging. In earlier studies, Wave-CAIPI cut scan times in half while still accurately identifying brain issues in children. Although image quality might be slightly lower, faster scans can be crucial in medical settings. In some cases, it even provided clearer details of certain brain problems compared to traditional methods. This trial will evaluate Wave-CAIPI in two groups: the Primary Testing Group and the Software Testing Group. This technology could make MRI scans quicker and possibly more detailed, which is important for diagnosing and monitoring conditions like low-grade gliomas. ^{1 3 4 6 7}

Who Is on the Research Team?

Kawin Setsompop, PhD

Principal Investigator

Boston Children Hospital/ Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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]

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 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]

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]

Citations

1. nature.com nature.com/articles/s41598-021-92759-y

Wave-controlled aliasing in parallel imaging ... - Nature Wave-CAIPI MPRAGE was a reliable method for diagnosing intracranial lesions in pediatric patients as conventional MPRAGE at half the scan time.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10162559/

Wave-controlled aliasing in parallel imaging (Wave-CAIPI) In the aspect of image quality, the overall image quality was reduced in Wave-CAIPI MPRAGE. Similar to the SNR, three times higher acceleration ...

3. dspace.mit.edu dspace.mit.edu/bitstream/handle/1721.1/142540/247_2021_5273_ReferencePDF.pdf?sequence=1&isAllowed=y

MIT Open Access Articles Wave controlled aliasing in parallel imaging (Wave-CAIPI) enables greater acceleration factors and might facilitate broader application of SWI, especially in ...

4. researchgate.net researchgate.net/publication/358358532_Evaluation_of_highly_accelerated_wave_controlled_aliasing_in_parallel_imaging_Wave-CAIPI_susceptibility-weighted_imaging_in_the_non-sedated_pediatric_setting_a_pilot_study

Evaluation of highly accelerated wave controlled aliasing ... Results: Wave-CAIPI SWI provided a 78% and 67% reduction in estimated scan time using the 32- and 20-channel coils, respectively, corresponding ...

5. ajnr.org ajnr.org/content/early/2019/11/14/ajnr.A6295

Validation of Highly Accelerated Wave–CAIPI SWI ... Wave–CAIPI SWI provided superior visualization of pathology and overall diagnostic quality compared with T2*W GRE and was noninferior to standard SWI with ...

6. ajnr.org ajnr.org/content/early/2021/07/08/ajnr.A7191

Evaluation of Ultrafast Wave–Controlled Aliasing in ... Highly accelerated imaging with Wave-CAIPI has been shown to reduce motion artifacts and improve the visualization of small lesions. In ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35119490/

Evaluation of highly accelerated wave controlled aliasing ... Highly accelerated Wave-CAIPI SWI of the brain can provide similar image quality to standard SWI, with estimated scan time reduction of 3-3.5 min.