Trial Summary
What is the purpose of this trial?This trial studies how well serial magnetic resonance (MR) imaging and MR spectroscopic imaging work in characterizing lower grade glioma. Diagnostic procedures, such as MR imaging and MR spectroscopic imaging, may detect serial changes in lower grade glioma. This study may help researchers learn more about practical ways of evaluating and standardizing treatment in patients with brain tumors.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment MRI + MRSI for brain tumors?
Research shows that Magnetic Resonance Spectroscopy (MRS) can enhance MRI by providing detailed information about brain metabolism, which helps in diagnosing brain tumors, distinguishing between different types of tumors, and monitoring treatment progress. MRS can guide surgeons to target the most aggressive parts of a tumor and avoid unnecessary surgery, potentially reducing surgical risks.
12345Is MRI + MRSI safe for use in humans?
MRI and MRSI are generally safe imaging techniques used in clinical practice to help diagnose and monitor brain tumors. They are non-invasive and do not involve radiation, making them safe for repeated use in humans.
36789How does the MRI + MRSI treatment for brain tumors differ from other treatments?
The MRI + MRSI treatment is unique because it combines magnetic resonance imaging (MRI) with magnetic resonance spectroscopic imaging (MRSI) to provide detailed metabolic information about brain tumors. This approach helps distinguish between tumor types and non-tumor conditions, potentially guiding treatment decisions and avoiding unnecessary surgery.
2371011Eligibility Criteria
This trial is for adults with lower grade glioma who are either being monitored or scheduled for treatment due to tumor recurrence. They must have a life expectancy over 12 weeks, be in good physical condition (Karnofsky score >60), not have severe heart issues, HIV, other cancers (except certain skin cancers/cervical carcinoma in-situ), and no major uncontrolled illnesses. Pregnant/breastfeeding women are excluded; others must use effective contraception.Inclusion Criteria
I haven't had a heart attack or unstable chest pain in the last year.
Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation
My kidney function is good, with creatinine below 1.5 mg/dL.
+10 more
Exclusion Criteria
Subjects will be excluded from participating in this study if they are unable to comply with study and/or follow-up procedures
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Imaging
Patients undergo MRI and MRSI scans at baseline to establish initial measurements
1 hour
1 visit (in-person)
Treatment/Monitoring
Patients receive hyperpolarized carbon C 13 pyruvate and continue with MRSI scans following clinical MRI schedule
Up to 4 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests how well serial MR imaging and MR spectroscopic imaging can track changes in lower grade gliomas over time. It aims to improve the evaluation of brain tumors and standardize treatments by using these advanced diagnostic procedures.
2Treatment groups
Experimental Treatment
Group I: Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI)Experimental Treatment3 Interventions
Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate IV over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.
Group II: Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT)Experimental Treatment2 Interventions
Patients undergo MRI and MRSI scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care. Participants enrolled in cohort 1 may later enroll in cohort 2 of study once eligibility has been reviewed and approved by neuro-oncologist
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, San FranciscoSan Francisco, CA
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Who Is Running the Clinical Trial?
Susan ChangLead Sponsor
National Cancer Institute (NCI)Collaborator
Phillips-MedisizeCollaborator
Sigma-AldrichCollaborator
GE HealthcareIndustry Sponsor
References
[Magnetic resonance spectroscopy in gliomas]. [2015]Magnetic resonance spectroscopy (MRS), that may be added to conventional magnetic resonance imaging (MRI) exam exhibit an increasing role in the management of brain tumors. These technique allow quantitative analysis of metabolites, either cell specific, either reflecting physiological and/or pathological process. With a rigorous approach, MRS explore brain metabolism that may improve MRI data in clinical practice in neuro-oncology. Positive diagnosis of brain tumor, differential diagnosis between infiltrative glioma (grade II) and gliomatosis, determination of the limits of tumor infiltration, and distinction between tumor and post-therapeutic images are some of the potential applications of MRS. Ongoing and future studies may also precise the place of MRS in the differential diagnosis between high grade glioma, metastasis and CNS lymphoma, as well as in monitoring therapy in glioma.
Multivoxel MR spectroscopic imaging--distinguishing intracranial tumours from non-neoplastic disease. [2020]Multi-voxel MR spectroscopic imaging (MRSI) provides chemical metabolite information that can supplement conventional MR imaging in the study of intracranial neoplasia. Our purpose was to use a robust semi-automated spectroscopic analysis to distinguish intracranial tumours from non-neoplastic disease.
(1)H MR spectroscopy of human brain tumours: a practical approach. [2021]Magnetic resonance spectroscopy (MRS) is proposed in addition to magnetic resonance imaging (MRI) to help in the characterization of brain tumours by detecting metabolic alterations that may be indicative of the tumour class. MRS can be routinely performed on clinical magnets, within a reasonable acquisition time and if performed under adequate conditions, MRS is reproducible and thus can be used for longitudinal follow-up of treatment. MRS can also be performed in clinical practice to guide the neurosurgeon into the most aggressive part of the lesions or to avoid unnecessary surgery, which may furthermore decrease the risk of surgical morbidity.
[Contribution of magnetic resonance spectrometry to the diagnosis of intracranial tumors]. [2015]Magnetic resonance spectroscopy (MRS) is a method enabling the analysis of the tissue metabolic content. It may offer a more accurate diagnosis of the intracranial tumors than conventional MRI sequences. MRS of normal brain parenchyma displays 4 main metabolites: N-acetyl aspartate (neuronal marker), creatine (cellular density marker), choline (membrane activity marker) and myoinositol (glial marker); pathological processes lead to variations of the level of these metabolites and/or the appearance of abnormal metabolites (lactate), following different patterns according to pathological process involved: glioma, meningioma, metastasis, bacterial or toxoplasmic abscess, radionecrosis. The potential clinical use of this method includes positive, differential and etiological diagnosis of tumors, determination of the level of malignancy of gliomas, screening for tumor recurrence following treatment. Our laboratory has been performing MR spectroscopic explorations of brain tumors for many years. Based on this experience, we show how MRS can be routinely performed in the clinical setting, what are its limitations and potential, and what kind of information can be supplied to the clinician.
Focal brain lesions: effect of single-voxel proton MR spectroscopic findings on treatment decisions. [2015]To determine the influence of single-voxel proton magnetic resonance (MR) spectroscopic findings on the treatment of patients suspected of having a brain tumor.
Considerations in applying 3D PRESS H-1 brain MRSI with an eight-channel phased-array coil at 3 T. [2007]The purpose of this study was to assess the benefits of a 3 T scanner and an eight-channel phased-array head coil for acquiring three-dimensional PRESS (Point REsolved Spectral Selection) proton (H-1) magnetic resonance spectroscopic imaging (MRSI) data from the brains of volunteers and patients with brain tumors relative to previous studies that used a 1.5 T scanner and a quadrature head coil. Issues that were of concern included differences in chemical shift artifacts, line broadening due to increased susceptibility at higher field strengths, changes in relaxation times and the increased complexity of the postprocessing software due to the need for combining signals from the multichannel data. Simulated and phantom spectra showed that very selective suppression pulses with a thickness of 40 mm and an overpress factor of at least 1.2 are needed to reduce chemical shift artifact and lipid contamination at higher field strengths. Spectral data from a phantom and those from six volunteers demonstrated that the signal-to-noise ratio (SNR) in the eight-channel coil was more than 50% higher than that in the quadrature head coil. For healthy volunteers and eight patients with brain tumors, the SNR at 3 T with the eight-channel coil was on average 1.5 times higher relative to the eight-channel coil at 1.5 T in voxels from normal-appearing brains. In combination with the effect of a higher field strength, the use of the eight-channel coil was able to provide an increase in the SNR of more than 2.33 times the corresponding acquisition at 1.5 T with a quadrature head coil. This is expected to be critical for clinical applications of MRSI in patients with brain tumors because it can be used to either decrease acquisition time or improve spatial resolution.
3D 1H MRSI of brain tumors at 3.0 Tesla using an eight-channel phased-array head coil. [2013]To implement proton magnetic resonance spectroscopic imaging (1H MRSI) at 3 Tesla (3T) using an eight-channel phased-array head coil in a population of brain-tumor patients.
Incorporation of a spectral model in a convolutional neural network for accelerated spectral fitting. [2023]MRSI has shown great promise in the detection and monitoring of neurologic pathologies such as tumor. A necessary component of data processing includes the quantitation of each metabolite, typically done through fitting a model of the spectrum to the data. For high-resolution volumetric MRSI of the brain, which may have ~10,000 spectra, significant processing time is required for spectral analysis and generation of metabolite maps.
Prospective serial proton MR spectroscopic assessment of response to tamoxifen for recurrent malignant glioma. [2021]Early prediction of imminent failure during chemotherapy for malignant glioma has the potential to guide proactive alterations in treatment before frank tumor progression. We prospectively followed patients with recurrent malignant glioma receiving tamoxifen chemotherapy using proton magnetic resonance spectroscopic imaging ((1)H-MRSI) to identify intratumoral metabolic changes preceding clinical and radiological failure.
Proton magnetic resonance spectroscopy imaging in the study of human brain cancer. [2013]Magnetic resonance spectroscopic imaging (MRSI) is a non-invasive imaging technique that provides metabolic information on brain tumor. This biochemical information can be processed and presented as density maps of several metabolites, among them N-acetylaspartate (marker of neuronal viability), choline (marker of membrane turnover), creatine (related to the energy state of the cells), myo-Inositol (exclusively found in astrocytes), lipids and lactate (observed in necrosis and other pathological processes) which mean relevant information in the context of brain tumors. Thus, this technique is a multiparametrical molecular imaging method that can complete the magnetic resonance imaging (MRI) study enabling the detection of biochemical patterns of different features and aspects of brain tumors. In this article, the role of MRSI as a molecular imaging technique to provide biochemical information on human brain tumors is reviewed. The most frequent questions and situations in the study of human brain tumors in clinical settings will be considered, as well as the distinction of neoplastic lesions from non neoplastic, the tumor type identification, the study of heterogeneity and infiltration of normal appearing white matter and the therapy following with detection of side effects. The great amount of data in MRSI acquisition compared to the single voxel techniques requires the use of automated methods of quantification, but the possibility to obtain self-reference in the non-affected areas allows different strategies for data handling and interpretation, as presented in the literature. The combination of MRSI with other physiological MRI techniques and positron emission tomography is also included in this review.
[Mapping of cerebral metabolism on cerebral disorders using multi-slice proton magnetic resonance spectroscopic imaging]. [2015]Multi-slice proton magnetic resonance spectroscopic imaging(MRSI) was performed using a 1.5 T clinical MR apparatus. Normal volunteer and several kinds of cerebral disorders were examined using following parameters; Tr/Te = 2.3 s/280 ms, slice thickness/gap/slices = 15/3.5 mm/4, 32 phase encoding and 24 cm FOV. Every 4 slice images of NAA, Cr, Cho and Lip/Lac were obtained in about 34 minutes. In control cases, images of Cr and Cho showed very high intensity at cerebellum comparing with cerebrum. This means high concentration or changes of relaxation times of both Cr and Cho. In cerebral infarction and brain tumor, though NAA images showed no signal intensity, Cr and Cho images showed small iso-or mild high-signal intensity areas. These findings suggest neuronal loss and gliosis or tumor growth in the lesions. In conclusion, MRSI has extremely high potential to evaluate metabolism of brain and cerebral disorders.