Neoplasms

All Conditions

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Glioma

Brain Neoplasms

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Nervous System Neoplasms

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Peripheral Nervous System Neoplasms

Neurofibromatosis

Neurofibromatosis Type 1

Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.

Magnetic Resonance Imaging

Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).

Magnetic Resonance Fingerprinting

Deborah R Gold, MD

This study will look at the feasibility of using magnetic resonance fingerprinting (MRF) in children, adolescents and young adults (AYA) with and without brain tumors. This study will also look at subjects with and without neurofibromatosis type 1(NF1), a genetic disorder that affects the growth of nervous system cells. Further, it will explore potential ways of using of MRF signal measurements in children, adolescents, and young adults with brain tumors, including tissue characterization, looking at whether the treatment was effective, and finding metastasized tumors of unknown origin (occult tumors). To explore the feasibility and potential applications of MRF, this study will recruit up to 80 subjects but will stop once 10 subjects have usable data in each of six groups.

Specific Aim 1: Demonstrate the feasibility of magnetic resonance fingerprinting (MRF) in children, adolescents and young adults (AYA) with and without brain tumors.

Specific Aim 2: Characterize the MRF signature of low-grade gliomas

Specific Aim 3: Determine whether MRF can identify occult tumor in subjects with low-grade glioma.

Specific Aim 4: Determine whether MRF can identify treatment effects in low-grade gliomas.

Specific Aim 5: Explore whether common brain tumors can be differentiated by comparing pre-operative MRF signature with pathologic diagnosis.

Outline: This study will examine the feasibility of MRF in children and AYA and determine whether quantitative measures of T1 and T2 relaxation times can be derived in subjects \<35 years of age. Approximately 80 subjects will be evaluated and include subgroups where MRF may be of particular utility, including children and AYA subjects with brain tumors and subjects with neurofibromatosis type 1 (NF1). Additional aims will investigate the utility of MRF in these groups.

Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

Descriptive statistics will be used to identify the T1 and T2 relaxation times for tumors of different types on pre-operative MRF scan

The duration of MRF sequence in minutes will be recorded as a measure of feasibility

Number of patients which have evaluable scans at both T1 and T2

Using Wilcoxon rank sum test to compare continuous variables, researchers will identify scans with significant difference in relaxometry between low-grade (composite of arms 1,3,4) and versus healthy brain tissue.

Using Wilcoxon rank sum test to compare continuous variables, researchers will identify scans with significant difference in relaxometry between high-grade (arm 6) and versus healthy brain tissue.

Using paired t-tests or non-parametric Wilcoxon signed rank tests, researchers will identify scans with significant differences in scans of treated and untreated tumors

Case Comprehensive Cancer Center

Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.

Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).

NF1-associated Optic Pathway Glioma (OPG)

Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.

Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).

NF1 Without Brain Tumor

Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.

Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).

Without NF1 and With Brain Tumor Exposed to Therapy

Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.

Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).

Without NF1 and With Untreated Low Grade Brain Tumors

Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.

Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).

Without NF1 and Without Brain Tumors

Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.

Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).

Brain Tumors of Assorted Pathology

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Deborah Runkin Gold

Average Duration of MRF Sequence - Feasibility

Number of Patients With Evaluable T1 and T2 Relaxation Times on MRF Scans

Arm 1: NF1-associated Optic Pathway Glioma (OPG) Arm 3: Without NF1 and with brain tumor exposed to therapy Arm 4: Without NF1 and with untreated low grade brain tumors

Arms 1, 3, and 4 - Low Grade Gliomas

Arms 1, 3, and 4 - Normal appearing white matter

Arms 1, 3, and 4 - Normal Appearing White Matter

Participants enrolled on arms 1,3 and 4. Combination of Arms 1, 3, and 4 for reporting was pre-specified in the study protocol. Each participant had a single tumor sample measured and a single normal-appearing white matter measured.

Comparison of Relaxometry MRI Scans Between Low Grade Gliomas and Healthy Brain Tissue

Arm 6 - High Grade Gliomas

Arm 6 - Normal Appearing White Matter

Participants in arm 6 had a measurable solid portion of HGG and were used for this analysis. Each participant had a single tumor sample measured and a single normal-appearing white matter measured.

Combination of Relaxometry MRI Scans Between High Grade Gliomas and Healthy Brain Tissue

Arm 1: NF1-associated Optic Pathway Glioma (OPG) Arm 4: Without NF1 and with untreated low grade brain tumors

The untreated LGG group consisted of Arm 4 and untreated participants from Arm 1.

Arms 1 & 4 - Untreated LGG

Arm 1: NF1-associated Optic Pathway Glioma (OPG) Arm 3: Without NF1 and with brain tumor exposed to therapy

The Treated LGG group consisted of Arm 3 and treated patients from Arm 1

Arms 1 & 3 - Treated LGGs

Participants enrolled in study. Combination of Arms for reporting was pre-specified in the study protocol

Comparison of Scans of Treated and Untreated Low Grade Gliomas (LGG)

Comparison of Relaxometry Values Between Tumors of Varying Pathology

Overall Study

Neoplasm Metastasis

Central Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Participants with newly diagnosed brain tumors will undergo Magnetic Resonance Fingerprinting (MRF) scan along with their clinical scan, followed by standard of care surgery, radiation, and chemotherapy. Follow-up MRF scans will be performed to visualize recurrence.

Participants with treated brain tumors with possible recurrence will undergo Magnetic Resonance Fingerprinting (MRF) scan along with their clinical scan, followed by standard of care surgery, radiation, and chemotherapy. Follow-up MRF scans will be added to the repeat MRI studies as determined appropriate by the referring physician/primary care team.

Non-contrast MRF acquisition will be acquired through the region of tumor in all patients. For patients receiving intravenous gadolinium based contrast, a post contrast MRF acquisition will also be acquired. This acquisition will be skipped in patients who do not receive or are not eligible for receiving IV contrast as a part of their clinical scan. The research scan will take approximately 10-15 minutes

Chaitra A Badve, MD

The purpose of the research study is to test new methods that could improve diagnosis and assessment of brain tumors. One of these methods is a new MR (magnetic resonance) imaging technique called magnetic resonance fingerprinting (MRF), which allows for rapidly scanning the patient and provides quantitative information on tumor tissue. The investigators will compare the data gathered from MR Fingerprinting with other imaging tests, clinical information, treatment details and biopsy results to evaluate the accuracy of this new technique.

The primary objective of this study is to 1) evaluate the utility of quantitative MRI imaging including 3D-MRF in differentiating among different brain tumors and differentiating recurrent brain tumor (TR) from treatment effects

Secondary objectives include evaluating the correlation between quantitative MRI imaging with histopathological characteristics and genetic markers in pre-therapy setting and with treatment response and clinical outcomes in post treatment setting.

GROUP 1: All patients with newly diagnosed intra-axial brain neoplasms undergo volumetric MRI study with contrast for surgical planning or clinical diagnosis. Diffusion, diffusion tensor imaging and perfusion imaging are often performed as a part of standard clinical imaging. In addition to these acquisitions, the research 3D-MRF acquisition through the entire tumor will be acquired. The imaging parameters will be correlated individually and in combination with biopsy/ resection outcomes.

GROUP 2: All patients with brain tumors who present at post therapy follow up with imaging progression undergo serial imaging as a part of clinical care. The research 3D-MRF acquisitions will be added to these clinical scans. All the quantitative parameters will be evaluated individually and in combination to differentiate post treatment changes from tumor recurrence.

Multi-Parametric Quantitative MR Imaging in Evaluation of Brain Tumors

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Other Dietary Supplements

All Drugs and Chemicals

Pyruvate

Patients receive hyperpolarized 13C pyruvate through IV injection less than 1-2 minute then undergo MRI over 3-5 minutes at baseline and 2 weeks after CCRT treatment. Total 2 times of MRI scan.

Procedure: Magnetic Resonance Imaging Undergo 1H-MRI of DWI/MRF/CEST for tumor cite following by 13C DNP-MRI for spleen for 3-5 minutes after hyperpolarized 13C pyruvate injection

Hyperpolarized 13C Pyruvate

Gigin Lin, MD, PhD

Kuan-Ying Lu, MS

In this single armed, single-center, case-controlled study, the investigators will conduct a prospective trial and integrate the most advanced imaging technology to medical practice, attempting to solve the problem detected by radiomics approach. The investigators plan a 3-year project with non-randomized, single group assignment observational study design. Thirty participants with diagnosed LACC that are to receive CCRT are to be recruited for this prospective single institutional study from Chang Gung Memorial Hospital at Linkou (CGMH). Standard-of-care MRI/CT that is required for staging will be the first line screening method. A tumor biopsy and routine blood test will be obtained at the time of the initial clinic visit. Participants eligible for this study will receive two investigative exams-MRF, CEST, DNP-MRI MRI and Metabolomics, at baseline and the 2-week during CCRT.

The new imaging methods being tested are MRF and CEST without contrast enhancement, and DNP-MRI which provides quantitative measurement of the metabolism occurring within cancer cells. It also involves injection of a contrast agent-Hyperpolarized pyruvate (13C) Injection. The participants will be injected with the study drug at a dose of 0.43 ml/kg and then receive MRI scan.

Primary objective

1. Bridging the Gap between Imaging and Biology. DNP is the only technology that can measure real-time flux of pyruvate to lactate conversion and mitochondria metabolism. DNP-MRI will combine the strength of MRI (anatomy, tissue contrast via MRF, CEST and DWI) and DNP (biochemistry measurement), and the blood/urine metabolomics approach, to noninvasively bring more insightful information for clinical application.
2. Precision Medicine for Precision Response Prediction. Although AI or deep learning can identify high-risk patient for particularly treatment (CCRT in this project), the predictive model is based on prior database rather than this particular patient. The investigators urgently need a non-invasive precise measurement to monitor the response in a real-world situation, to reduce the treatment uncertainty, to select the most cost-effective treatment. This is of paramount importance for the more advanced treatment i.e. target therapy, immunotherapy etc. The investigators did not intend to change the standard-of-care but the information provided by this study will help to investigate the fundamental mechanisms hence providing hopes for alternative treatments.
3. Infrastructures for MR Fingerprinting and Dynamic Nuclear Polarization (DNP)-MRI Research for Taiwanese researchers. The investigators are very grateful to be able to install the first DNP system dedicated to human research in Asia and would like to introduce this novel technology to Taiwan. Currently, human DNP study has only been conducted in the USA (UCSF, MD Anderson Cancer Center and Memorial Sloan-Kettering Cancer Center) and the UK (University College of London, Oxford and Cambridge) and Canada (Toronto University). Based on our preliminary efforts of tracer preparation, multi-nuclei scanning equipment and dedicated pulse sequences, the investigators aim to build infrastructures for MR Fingerprinting and DNP-MRI Research for Taiwanese research groups.

Secondary objective

1. Translate technical advancements to clinically applicable tools
2. Converge integrated information to construct the prediction model
3. Establish the delta radiomics prediction model with biological meaningfulness

Hyperpolarized 13C Pyruvate MRI for Early Immune Evaluation in Cervical Cancer Patients at Baseline and CCRT Therapy

Precision Medicine Imaging for Cervical Cancer: Integrating MR Fingerprinting, Dynamic Nuclear Polarization (DNP)-MRI and Artificial Intelligence Radiomics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility and Clinically Application of Magnetic Resonance Fingerprinting	NCT02387840	Neurofibromatos... Brain Tumor Glioma	Magnetic Resona... Magnetic Resona...	- 35 Years	Case Comprehensive Cancer Center
Multi-Parametric Quantitative MR Imaging in Evaluation of Brain Tumors	NCT02956291	Brain Tumor	Magnetic Resona...	18 Years -	Case Comprehensive Cancer Center
Hyperpolarized 13C Pyruvate MRI for Early Immune Evaluation in Cervical Cancer Patients at Baseline and CCRT Therapy	NCT04951921	Cervical Cancer	Hyperpolarized ...	20 Years -	Chang Gung Memorial Hospital
Feasibility and Clinically Application of Magnetic Resonance Fingerprinting	NCT02387840	Neurofibromatos... Brain Tumor Glioma	Magnetic Resona... Magnetic Resona...	- 35 Years	Case Comprehensive Cancer Center

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