AI-Enhanced MRI for Detecting Precancerous Lesions in Neurofibromatosis

Recruiting in Palo Alto (17 mi)

Overseen by Nicole Baca, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Nicole Baca

Disqualifiers: Sedation, Implants, Claustrophobia, Allergy, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses a full-body scan and smart computer software to monitor changes in pediatric patients with neurofibromatosis type 1. The MRI takes detailed images, and the AI analyzes them to track any changes over time.

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 Whole-body Magnetic Resonance Imaging (WB-MRI) for detecting precancerous lesions in Neurofibromatosis?

Research shows that whole-body MRI is valuable for assessing tumor burden and differentiating between benign and malignant tumors in patients with neurofibromatosis type 1. This suggests that WB-MRI can be an effective tool for detecting changes in tumors, which may help in identifying precancerous lesions. ^{1 2 3 4 5}

Is whole-body MRI safe for humans?

Whole-body MRI has been used in patients with neurofibromatosis, and while the studies focus on its effectiveness, they do not report any specific safety concerns, suggesting it is generally safe for human use. ^{1 2 5 6 7}

How is the treatment Whole-body MRI unique for detecting precancerous lesions in neurofibromatosis?

Whole-body MRI is unique because it allows for a comprehensive scan of the entire body, which helps in accurately measuring the total tumor volume in patients with neurofibromatosis type 1. This method is enhanced by AI, which improves the detection and measurement of tumors, making it more precise than traditional imaging techniques. ^{1 2 5 8 9}

Research Team

Nicole Baca, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Whole-body Magnetic Resonance Imaging (Procedure)

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.

Participant Groups

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

Who Is Running the Clinical Trial?

Nicole Baca

Lead Sponsor

Trials

1

Recruited

20+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Whole body MR imaging in neurofibromatosis type 1. [2009]

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

Tumor segmentation of whole-body magnetic resonance imaging in neurofibromatosis type 1 patients: tumor burden correlates. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Image-Based Differentiation of Benign and Malignant Peripheral Nerve Sheath Tumors in Neurofibromatosis Type 1. [2022]

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

Longitudinal Assessment of Enhancing Foci of Abnormal Signal Intensity in Neurofibromatosis Type 1. [2022]

5. United States 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. [2017]

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

Current whole-body MRI applications in the neurofibromatoses: NF1, NF2, and schwannomatosis. [2022]

7. England 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. [2022]

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

Automated detection and volume measurement of plexiform neurofibromas in neurofibromatosis 1 using magnetic resonance imaging. [2004]

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

Synthetic MRI in Neurofibromatosis Type 1. [2022]