AI-Enhanced MRI for Detecting Precancerous Lesions in Neurofibromatosis

Overseen By Clinical Trial Recruitment Navigator

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Nicole Baca

Disqualifiers: Sedation, Implants, Claustrophobia, Allergy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a whole-body MRI scan, enhanced with artificial intelligence, can reliably detect precancerous lesions in children with neurofibromatosis type 1. The researchers will assess the method's effectiveness by comparing scans taken a year apart. Children diagnosed with neurofibromatosis type 1 who can undergo an MRI without sedation may be suitable candidates for this trial. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research in early detection methods.

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 MRI technique is safe for pediatric patients with neurofibromatosis type 1?

Research has shown that whole-body Magnetic Resonance Imaging (MRI) is generally safe and well-tolerated. This imaging method is commonly used to screen adults and children at higher risk of cancer. Studies have found it effective for diagnosing and evaluating tumors in individuals with neurofibromatosis type 1 (NF1), a genetic disorder. Importantly, these studies have not reported any major safety concerns, suggesting that whole-body MRI is a safe option for those considering joining clinical trials using this imaging technique. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using AI-enhanced MRI for detecting precancerous lesions in patients with Neurofibromatosis because it offers a cutting-edge approach to early detection. Unlike traditional MRI scans, this method leverages artificial intelligence to enhance image clarity and accuracy, potentially spotting lesions that might otherwise go unnoticed. This could lead to earlier intervention and better outcomes for patients, as finding these lesions early can be crucial in managing the condition effectively. By integrating AI with MRI technology, this technique promises a more precise and efficient diagnostic process, which is why it's generating so much enthusiasm within the medical community.

What evidence suggests that this whole-body MRI is effective for detecting precancerous lesions in neurofibromatosis?

Studies have shown that whole-body Magnetic Resonance Imaging (MRI) can help detect tumors in individuals with neurofibromatosis type 1 (NF1). Research suggests that this imaging method identifies patients with more tumors, potentially leading to serious issues like cancer. Whole-body MRI is becoming a valuable tool for monitoring and understanding NF1. It can detect changes early, which is crucial for better health outcomes. This imaging technique holds promise because it aids doctors in understanding and managing NF1 more effectively. ^{1 2 6 7 8}

Who Is on the Research Team?

Nicole Baca, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for pediatric patients aged 5 to less than 18 with confirmed Neurofibromatosis Type 1. It's open even if they turn 18 during the study. However, it excludes those needing sedation for imaging, with allergies to animal dander or asthma triggered by animals, ferromagnetic implants or foreign bodies, and claustrophobia.

Inclusion Criteria

I have been diagnosed with NF-1, including a less common form known as mosaic NF-1.

I am between 5 and 17 years old.

Exclusion Criteria

I am claustrophobic or cannot lie on my back.

You are allergic to animal fur or have asthma triggered by animals.

You have certain implants or devices that could be affected by magnets or electricity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Initial whole-body Magnetic Resonance Imaging scan using T2 imaging to establish baseline metrics

1 day

1 visit (in-person)

Scan-Rescan Reliability

Participants undergo a second T2 imaging scan to evaluate scan-rescan reliability within 4 weeks of the baseline scan

4 weeks

1 visit (in-person)

Longitudinal Follow-up

Participants undergo T1 and ACD imaging to assess changes over time, with a third scan performed 12 months after the baseline scan

12 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging interventions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Whole-body Magnetic Resonance Imaging

Trial Overview The trial tests a new whole-body MRI technique paired with AI in detecting pre-malignant lesions in kids with Neurofibromatosis Type 1. The goal is to check how reliable the scans are over time and predict changes from initial scan to follow-up at one year.

How Is the Trial Designed?

Group I: Whole-Body Magnetic Resonance Imaging Experimental Treatment 1 Intervention

Whole-body Magnetic Resonance Imaging is already approved in United States, European Union for the following indications:

Approved in United States as Whole-body MRI for:

• Diagnostic imaging for neurofibromatosis type 1
• Monitoring of pre-malignant lesions

Approved in European Union as Whole-body MRI for:

• Diagnostic imaging for neurofibromatosis type 1
• Monitoring of pre-malignant lesions

Who Is Running the Clinical Trial?

Nicole Baca

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

Synthetic MRI effectively detects and characterizes focal areas of signal intensity in the brains of patients with neurofibromatosis type 1, showing a strong correlation with conventional MRI results.

The study found significant morphometric changes in patients, including increased brain volumes and decreased myelin-related metrics in affected areas, indicating potential tissue alterations associated with the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthetic MRI in Neurofibromatosis Type 1. Coban, G., Parlak, S., Gumeler, E., et al.[2022]

In a study of 19 patients with neurofibromatosis 1, 23 rare contrast-enhancing lesions were observed, with many showing regression over time, particularly in the splenium of the corpus callosum and cerebellum.

Regular follow-up MR imaging is crucial for monitoring these lesions, as atypical changes may indicate the presence of underlying tumors, emphasizing the need for careful evaluation in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal Assessment of Enhancing Foci of Abnormal Signal Intensity in Neurofibromatosis Type 1. Hainc, N., Wagner, MW., Laughlin, S., et al.[2022]

Segmentation of whole-body MRI (WBMRI) in 15 patients with neurofibromatosis type 1 (NF1) was successful, identifying a total of 2,328 tumors, which included superficial, internal, and plexiform types, demonstrating the method's feasibility for assessing tumor burden.

The study found significant correlations between tumor volume and patient characteristics, such as height and gender, with male patients showing higher tumor burdens, indicating that demographic and anthropomorphic features may influence tumor development in NF1.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor segmentation of whole-body magnetic resonance imaging in neurofibromatosis type 1 patients: tumor burden correlates. Heffler, MA., Le, LQ., Xi, Y., et al.[2018]

Multiparametric whole-body MRI (WBMRI) detected significantly more tumors in patients with neurofibromatosis type 1 (NF1) compared to whole-spine MRI (WSMRI), identifying 2766 tumors versus 2602 missed by WSMRI, indicating its superior efficacy in assessing tumor burden.

WBMRI not only provided a more comprehensive view of tumor locations and volumes but also demonstrated excellent interobserver reliability for measuring tumor characteristics, making it a preferred imaging method for evaluating NF1 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Value of Multiparametric Whole-Body Magnetic Resonance Imaging over Whole-Spine Magnetic Resonance Imaging in Patients with Neurofibromatosis Type I. Zhang, L., Dessouky, R., Xi, Y., et al.[2017]

In a study of 70 NF1 patients under 3 years old, whole-body magnetic resonance imaging (WBMRI) revealed that focal areas of signal intensity (FASI) were the most common finding, indicating early signs of disease progression in young children with NF1.

The presence of specific NF1 mutations, particularly those involving the GTPase activating protein-related domain, was associated with a higher frequency of radiologic progression, suggesting that genetic factors play a significant role in the severity and progression of NF1.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-body MRI evaluation in neurofibromatosis type 1 patients younger than 3 years old and the genetic contribution to disease progression. Kang, E., Kim, YM., Choi, Y., et al.[2022]

Neurofibromatosis type 1 (NF1) affects 1 in 3000 individuals and is associated with benign tumors that can transform into malignant tumors, making early differentiation crucial for patient outcomes.

Current imaging methods like CT and MRI are used for monitoring tumors in NF1 patients, but there is no consensus on how to effectively screen for malignant transformations; new technologies like radiogenomics and PET-MRI show promise but need further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-Based Differentiation of Benign and Malignant Peripheral Nerve Sheath Tumors in Neurofibromatosis Type 1. Liu, J., Huang, JN., Wang, MH., et al.[2022]

An automated technique for measuring plexiform neurofibromas (PN) in patients with neurofibromatosis 1 was developed and validated, showing high reproducibility with a low coefficient of variation (0.6-5.6%).

This method produced results that closely matched manual measurements (R = 0.999), suggesting it could enhance the accuracy and efficiency of tumor volume assessments in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated detection and volume measurement of plexiform neurofibromas in neurofibromatosis 1 using magnetic resonance imaging. Solomon, J., Warren, K., Dombi, E., et al.[2004]

Whole-body MRI (WB-MRI) is a feasible imaging technique for detecting tumors in patients with neurofibromatosis type 1 (NF1), neurofibromatosis type 2 (NF2), and schwannomatosis (SWN), using both 1.5T and 3.0T MRI systems.

The short tau inversion recovery (STIR) sequence is consistently used across studies, indicating its effectiveness for identifying tumor burden, but further research is needed to determine the best imaging techniques and the reproducibility of WB-MRI results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current whole-body MRI applications in the neurofibromatoses: NF1, NF2, and schwannomatosis. Ahlawat, S., Fayad, LM., Khan, MS., et al.[2022]

Whole body MR imaging is an effective tool for assessing neurofibromas in patients with neurofibromatosis type 1 (NF1), allowing for detailed evaluation of their distribution, size, and morphology in a study of 24 patients.

The imaging successfully distinguished neurofibromas from other structures like lymph nodes and cysts, and revealed a variety of neurofibroma types, including superficial and deep lesions, with no correlation found between age and the total number of neurofibromas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole body MR imaging in neurofibromatosis type 1. Van Meerbeeck, SF., Verstraete, KL., Janssens, S., et al.[2009]

Citations

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Whole-body magnetic resonance imaging (WB-MRI) for ... In this systematic review, we analyse the methodology and the results of the original research articles covering the use of WB-MRI for cancer screening in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01777451

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4. hopkinsmedicine.org hopkinsmedicine.org/neurology-neurosurgery/specialty-areas/neurofibromatosis/clinical-trials

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6. sciencedirect.com sciencedirect.com/science/article/pii/S0022202X2400112X

Whole-Body Positron Emission Tomography with 18F ... This study emphasizes the diagnostic and screening performances of whole-body positron emission tomography with 18F-fluorodeoxyglucose/magnetic resonance ...

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8. neurology.org neurology.org/doi/10.1212/WNL.0000000000009490

Correlation between NF1 genotype and imaging ... Whole-body MRI (WBMRI) with volumetric imaging analysis provides a quantitative imaging biomarker for reliable measurements of tumor burden in patients with NF1 ...