Treatment Trials

159 Clinical Trials for Various Conditions

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RECRUITING
Establishing Daily Applicable Parameters for Using Magnetic Resonance Spectroscopy of Spinal Cord
Description

To learn if MRS can effectively assess spinal cord lesions.

Conditions
RECRUITING
MAGNETIC RESONANCE SPECTROSCOPY BIOMARKERS IN TYPE 3 GAUCHER DISEASE (GD3)
Description

Recent studies have has shown that magnetic resonance spectroscopy (MRS) can provide validated neuronal markers in patients with Type 1 GD (GD1) who are on stable therapy. However, alterations in neurometabolites in adult patients with GD3, who have established neurological involvement, are not well understood. The goal of this study is to characterize neurometabolite profiles in adult patients with GD3 using MRS to identify novel biomarkers that can demonstrate treatment response. Additionally, a secondary aim is to evaluate relationships between neurometabolites and disease parameters, such as genotype, enzyme levels and Gaucher disease (GD) biomarkers.

RECRUITING
Aging and the Mitochondrial Response to Exercise Training, Measured by Noninvasive 31P Magnetic Resonance Spectroscopy
Description

The goal of the study is to determine whether aerobic or resistant exercise can improve in vivo mitochondrial capacity of skeletal muscle cells similarly in healthy younger, middle aged and older adults. This confers long-term changes in this tissue which in-turn contribute to improved metabolic health and functional capacity through epigenetic regulation of novel exercise response genes.

TERMINATED
7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin Associated Adverse Muscle Events
Description

Over 40 million Americans take statins to reduce their risk of atherosclerotic cardiovascular disease (ASCVD). Unfortunately, 10 to 20% stop taking them due to statin-associated muscle symptoms (e.g. pain, aches, weakness, cramps, or stiffness) (1, 2). The pathophysiology of these statin-associated muscle symptoms (SAMS) has remained elusive. Consequently, no objective diagnostic method exists, causing confusion for patient and providers since muscle symptoms can often be multifactorial.

COMPLETED
Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid
Description

A dose-escalation study to determine the optimum dose of Clavulanic Acid (CLAV) for effects on craving and efficacy.

WITHDRAWN
Magnetic Resonance Spectroscopy Studies of Acute Hypoxic and Hyperoxic Breathing in Healthy Volunteers
Description

This study evaluates the impact of hypoxic and hyperoxic breathing on measures of brain redox balance and metabolism in healthy individuals. All participants will undergo an MRI scan during administration of air mixtures with different oxygen concentrations to collect the brain measures.

Conditions
COMPLETED
Identifying Biomarkers That Distinguish PTSD and mTBI Using Advanced Magnetic Resonance Spectroscopy
Description

The purpose of this study is to develop a new test to help diagnose mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) in soldiers. Chemicals in the brain will be measured using a Magnetic Resonance Spectroscopy (MRS) scan. In the study, the investigators will compare the information they obtain from scans of participants with mTBI, PTSD or both, to scans from healthy volunteers to understand the differences between these groups. If the results can tell the difference between participants with mTBI and PTSD, the investigators should be able to help safely diagnose patients in the future.

COMPLETED
Predicting Treatment Response to Memantine in Autism Using Magnetic Resonance Spectroscopy
Description

Memantine, an N-methyl-D-aspartate receptor antagonist, has been explored as a possible therapeutic agent that reduces the excitatory (glutamate) - inhibitory (gamma amino-butyric acid, GABA) imbalance in autism pathology and improves social and communication deficits. While some studies have shown positive results, a large clinical trial failed to show benefit possibly because different subsets of autism responded differently to the treatment. The investigator proposes a pilot, exploratory, clinical follow-on study using proton magnetic resonance spectroscopy (1H-MRS) to determine whether baseline glutamate/GABA levels in certain regions of the brain may help predict treatment response to Memantine in autistic subjects. At study onset, subjects will be assessed on the behavioral scales such as the Aberrant Behavior Checklist and Clinical Global Impressions scale, followed by MRS imaging. Memantine treatment will be started post imaging. Assessment measures will be repeated at week 12 during treatment. Glutamate and GABA levels in brain regions will be correlated to improvements on assessment measures. Expected results include higher glutamate and/or lower GABA levels in the anterior cingulate cortex at baseline in responders to memantine. If the hypotheses are confirmed, it will provide evidence of a relevant neural biomarker to predict treatment response to memantine with important implications for clinical care including improving individualization of treatments.

COMPLETED
Testing Glial Pathways to HAAF in Human Subjects Using Carbon 13 Magnetic Resonance Spectroscopy
Description

Hypoglycemia-associated autonomic failure (HAAF), a condition commonly developed in diabetic patients, which causes them to have severely low blood sugar levels. This condition makes clinical management of blood sugar in diabetic patients very challenging. This research seeks to better understand how diabetic patients develop HAAF, and what can be done to prevent it.

COMPLETED
Magnetic Resonance Spectroscopy (MRS) in Midlife Depression
Description

The purpose of this study is to determine the impact of inflammation on central nervous system (CNS) glutamate, white matter pathology and alterations in behavior and cognition in middle-aged patients with major depression. Depression is associated with significant alterations in glutamate concentrations and white matter integrity, which has been associated with decreased antidepressant response, poor functional outcome, and cognitive impairment.

ACTIVE_NOT_RECRUITING
High-field Brain Magnetic Resonance Spectroscopy
Description

Magnetic resonance spectroscopy (MRS) allows non-invasive measurement of the concentration of up to 18 metabolites in the brain ("neurochemical profile"). The objective of this proposal is to develop new methods for high-field brain MRS (3 to 7 Tesla). Our main hypothesis is that higher magnetic fields lead to improved spatial and temporal resolution and improved quantification precision. Aims 1. To obtain improved "neurochemical profiles" in the brain using single voxel proton MRS at very high field (3 Tesla to 7 Tesla). 2. To develop new methods for proton magnetic resonance spectroscopic imaging (MRSI) to obtain metabolic maps at very high field (3 Tesla to 7 Tesla). Since this project is focused on technical development, only healthy volunteers will be recruited (no patients).

Conditions
TERMINATED
Magnetic Resonance Spectroscopy in Autonomic Failure
Description

This research study will be conducted in patients with primary autonomic failure, a disabling condition that is associated with low blood pressure upon standing. These patients are also not able to control for changes in their blood pressure due to a loss of cardiovascular reflexes that are mediated within the brain. The purpose of this study is to determine whether magnetic resonance spectroscopy (MRS), a non-invasive imaging technique, can measure levels of chemicals (neurotransmitters) in the dorsal medulla, a brain area important for control of cardiovascular function, in autonomic failure patients. Importantly, this study will determine whether there are differences in brain chemicals between patients with peripheral versus central origins of their autonomic failure. The hypothesis is that the neurotransmitter profile in the medulla will be intact in patients with peripheral autonomic failure compared to those with central impairment. Overall, this study will provide insight into understanding the mechanisms involved in autonomic failure and will determine whether a single session of MRS imaging can improve the ability to make an accurate diagnosis in these patients. This would lessen the need for more extensive and invasive clinical testing.

COMPLETED
Pilot Study Effect of Sulfasalazine on Glutamate Levels by(Magnetic Resonance Spectroscopy)MRS in Patients With Glioma
Description

The main purpose of this part of the study is to determine the Central Nervous System bioavailability of sulfasalazine.

Conditions
COMPLETED
Magnetic Resonance Spectroscopy Imaging in Predicting Response to Vorinostat and Temozolomide in Patients With Recurrent or Progressive Glioblastoma
Description

This clinical trial is studying magnetic resonance spectroscopy imaging in predicting response in patients to vorinostat and temozolomide in patients with recurrent, progressive, or newly diagnosed glioblastoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may also help temozolomide work better by making tumor cells more sensitive to the drug. Imaging procedures, such as magnetic resonance spectroscopy imaging, may help measure the patient's response to vorinostat and temozolomide and allow doctors to plan better treatment.

COMPLETED
Defining 31Phosphorous Magnetic Resonance Spectroscopy Characteristics in Patients With Mitochondrial Myopathy
Description

This is a developmental protocol to determine the MRI based 31P-MRS changes seen in subjects with mitochondrial myopathy using our dynamic exercise protocol and to identify the ideal variable(s) to represent mitochondrial function.

COMPLETED
Phosphorous Magnetic Resonance Spectroscopy of Heart
Description

Heart needs constant supply of energy to continue working. Phosphorus magnetic resonance spectroscopy allows us to measure energy produced in the heart. The purpose of this study is to determine if the energy production is reduced in failing heart.

COMPLETED
Magnetic Resonance Spectroscopy (MRS) Validation Study in Individuals With Nonalcoholic Fatty Liver Disease (NAFLD)
Description

The purpose of this study is to see how effective the investigators' optimized magnetic resonance spectroscopy (MRS) sequence in quantifying hepatic triglyceride content (HTGC) to enhance MRS as a diagnostic tool in non-alcohol fatty liver disease (NAFLD).

Conditions
WITHDRAWN
Evaluation of Skeletal Muscle Lipid Content by Magnetic Resonance Spectroscopy
Description

Type 2 diabetes is a growing public health issue and one component of Type 2 diabetes is 'insulin resistance" - the ability of insulin to work less well. The skeletal muscle is one of the largest users of sugar in the body, when the skeletal muscle is "insulin resistant", this contributes to diabetes. There is some evidence that the amount of fat in the skeletal muscle is related to the amount of insulin resistance. We are asking people to participate in a study to look at the amount of fat in muscle and how this fat amount changes with exercise. We hypothesize that heavier people will have higher amounts of fat and deplete this fat more slowly than lean subjects.

Conditions
COMPLETED
Magnetic Resonance Spectroscopy, Perfusion, and Diffusion Tensor Imaging in Neuropsychiatric Lupus
Description

The purpose of this study is to determine if three functional Magnetic Resonance brain imaging techniques: Magnetic Resonance Spectroscopy(MRS),Magnetic Resonance perfusion, and Diffusion Tensor Imaging(DTI) can detect brain alterations distinctive for neuropsychiatric systemic lupus erythematosus (NPSLE)and systemic lupus erythematosus(SLE).

COMPLETED
Magnetic Resonance Spectroscopy, Perfusion and Diffusion Tensor Imaging in Neuropsychiatric Lupus
Description

The purpose of this study is to find out if certain types of Magnetic Resonance (MR) scanning will help to better detect markers in the brain that are related to the neuropsychiatric symptoms of systemic lupus erythematosus (SLE). A small percentage of patients who have this type of lupus experience symptoms that may result from a blood clot or change in blood vessel structure in the brain. These neuropsychiatric symptoms can include an inability to think clearly, a change in level of awake and/or awareness, and in the worst cases, seizure and stroke. Another goal of the study is to find out if individuals with fibromyalgia (FM), or chronic pain, have symptom-related markers in any of these scans as well. Better and earlier detection of markers that are related to acute neuropsychiatric lupus (NPSLE) and FM will be helpful to all who are affected by these diseases.

COMPLETED
MRI and Magnetic Resonance Spectroscopy Imaging in Patients Receiving Dutasteride for Benign Prostatic Hypertrophy and Low-Risk Prostate Cancer
Description

RATIONALE: Diagnostic procedures, such as MRI and magnetic resonance spectroscopy imaging, may help in learning how well dutasteride works in patients with benign prostatic hypertrophy and low-risk prostate cancer. PURPOSE: This clinical trial is studying MRI and magnetic resonance spectroscopy imaging in patients receiving dutasteride for benign prostatic hypertrophy and low-risk prostate cancer.

WITHDRAWN
Examination of Changes on Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) in Patients Who Receive Gliadel Wafers During Initial Surgery for Glioblastoma Multiforme. Response or Failure to Gliadel Wafers for Subjects With Glioblastoma Multiforme.
Description

Subjects with newly diagnosed brain tumors who undergo surgical resection and whose pathology in the operating room shows a high grade glioma will be eligible. During a screening visit, the study will be discussed, inform consent discussed and signed, a medical history will be taken and a physical examination and laboratory tests will be performed. If these tests are all within acceptable ranges, the subject will be considered for inclusion on this treatment protocol. If the results of any tests are extremely different from normal expected values, she/he may not be able to participate. Prior to surgery, the subject will have a contrast enhanced MRI and MRS. The neurosurgeon will attempt to remove the majority of the tumor in the operating room and will send a portion of the specimen removed to the pathologist immediately. This is called a "frozen section". If the pathologist believes that the tumor is a high-grade malignant brain tumor, then the surgeon will place up to 8 dime-sized chemotherapy wafers in the tumor cavity of the brain. The remainder of the tumor specimen will be given to the pathologist to review more closely in the laboratory. If the frozen section does not show that the tumor is a high-grade malignant brain tumor, the subject will not receive the Gliadel wafers and will be removed from the study. The surgeon will then discuss with the subject the appropriate treatment options for the disease he or she has. During recovery in the hospital, another contrast enhanced MRI will be performed within the first 72 hours after surgery. This is a standard of care for patients who are not involved on this protocol as well. The subject will have another contrast enhanced MRI and MRS performed at the 21st Day after his or her surgery. After Day 21, He or she may begin other forms of treatment. The last contrast enhanced MRI and MRS assessment will be performed 12 weeks after the surgery and the implantation of the Gliadel wafers. Further MRI and MRS may be performed subsequently at the discretion of the doctor. Throughout the course of treatment, clinical data will be collected.

COMPLETED
Evaluate the Use of the Magnetic Resonance Spectroscopy in Determining if the Breast Tumor is Benign or Malignant
Description

Magnetic Resonance Spectroscopy (MRS) is a novel imaging technique for noninvasive probing of biochemical properties of tissue. While MRS does not generate images of tumor per se it allows biochemical spectroscopic data to be obtained in vivo from user defined region-of-interest. In this manner, biochemical information elucidated by MRS can be interpreted in relation to detailed anatomy and images of metabolite distribution can be created. The aim of MRS is to identify presence and concentration of metabolites characteristic for normal and abnormal (tumor) cellular activities hence allow differential normal tissue from pathological tissue, as well as allow differentiating malignant from benign tumors.

Conditions
ACTIVE_NOT_RECRUITING
Dynamic Contrast Enhanced MRI (DCE-MRI) Diffusion Weighted MRI (DW-MRI) and Magnetic Resonance Spectroscopy (MRS) of Head and Neck Tumors
Description

Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) uses faster imaging and contrast material (a substance used to make specific organs, blood vessels, or tumors easier to see) that is given by vein. Diffusion weighted magnetic resonance imaging (DW-MRI) allows to measure the motion of water around the cells in the tumor. Proton magnetic resonance spectroscopy (MRS) obtains chemical information from the tumor. During MRS, signals are detected from the chemicals (spectroscopy) naturally present in your tumor using radio waves. DCE-MRI, DW-MRI and MRS give extra information which is not available with the regular MRI. The regular MRI only shows pictures of the tumor while the DCE-MRI also gives information about the blood vessels of the tumor. DW-MRI provides information related to the state of the tumor tissue with regards to the quality or condition of cells present in it and MRS gives information about the chemical makeup of the tumor. The purpose of this study is to see whether DCE-MRI, DW-MRI and MRS done before treatment can predict which patients will do well with either surgery or chemo-radiation therapy. This study will also see if DCE-MRI, DW-MRI and MRS done early in treatment can tell if the therapy is working.

COMPLETED
Magnetic Resonance Spectroscopy Study of Memantine in Alzheimer's Disease
Description

We are studying subjects with mild to moderate Alzheimer's disease who have been on a stable dose of any cholinesterase inhibitor \[donepezil (Aricept), rivastigmine (Exelon), or galantamine (Razadyne)\] for at least 3 months, and have not previously taken memantine (Namenda). This is an open-label study, with magnetic resonance spectroscopy (MRS) as the primary outcome measure, along with neuropsychological testing, and optional lumbar puncture, evaluating patients on their stable dose of a cholinesterase inhibitor over 24 weeks, followed by another 24 weeks on memantine in combination with stable dose of cholinesterase inhibitor. The purpose of this study is to characterize the progression of disease using MRS, cerebrospinal fluid (CSF) biomarkers, and cognitive outcome measures, and to determine whether changes in cognitive function on neuropsychological testing are correlated to changes in MR spectroscopic and/or CSF biomarkers.

COMPLETED
Non-Invasive Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy Techniques (MRS) for Assessing Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
Description

The goal of this clinical research study is to learn if magnetic resonance imaging (MRI) with magnetic resonance spectroscopy (MRS) can show the effects of pre-surgical chemotherapy in breast cancer patients who are eligible to receive preoperative chemotherapy.

Conditions
COMPLETED
Quantification of Intramyocardial Lipid by Proton Magnetic Resonance Spectroscopy
Description

Accumulation of triglycerides in heart tissue has been associated with changes in left ventricular function which can lead to heart failure. Proton magnetic resonance spectroscopy is currently the only non-invasive in vivo method to measure myocardial triglycerides content. The primary goal of this study was to determine if Magnetic Resonance Spectroscopy could effectively measure myocardial triglyceride content in myocardial heart tissue. Thus, quantitative and reliable techniques to monitor in vivo triglyceride accumulation in the heart are important for disease diagnosis and management. Currently, no such imaging method exists.

COMPLETED
Janssen Asperger's MRS (Magnetic Resonance Spectroscopy Risperidone Study
Description

This study will be an open-label, 12-week trial of risperidone in subjects with Asperger's Disorder, according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) Criteria. The study has two arms, one involving pre- and post-treatment MRS studies, and one without MRS. The MRS arm will study 18-20 subjects ages 6 and above, with a target of 14 completing patients. For both arms, we plan to a enroll at total of 30 patients to achieve completion for 24 patients. The non-MRS arm of the study will include subjects 6-18 years of age, the bulk of which have completed the study as of the writing of this updated revision. Our hypotheses are that treatment of Asperger's patients with a low dose of risperidone will: 1. decrease ratios of N-acetylaspartate (NAA), creatine, phosphocreatine (Cr + PCr), and choline in the prefrontal lobe, and 2. decrease the severity of negative symptoms and overall improve social behavior, and 3. that the two will be correlated. Specific Aims The primary objectives of this trial are to: * Further assess and investigate the utility of risperidone in the treatment Asperger's disorder. * Assess the efficacy of risperidone in normalizing increased frontal lobe metabolites. * Assess the efficacy of risperidone in normalizing symptoms in Asperger's disorder patients using standardized rating scales to assess the impact on negative symptoms and on social interaction. * Determine whether risperidone's effect on clinical improvement of Asperger's disorder, i.e., negative symptoms, is correlated with normalization of frontal lobe metabolites * Accrue safety and tolerability data on risperidone for this population of patients. This information could potentially be used to provide pilot data for a double blind trial

WITHDRAWN
Using Magnetic Resonance Spectroscopy With MRI to Non-invasively Determine Breast Cancer Extent of Disease
Description

The purpose of this study is to evaluate whether high-resolution magnetic resonance imaging of the axilla with spectroscopy can identify nodal features suggestive of metastatic involvement in patients diagnosed with invasive breast cancer. This may enable us to define a select group of patients for whom axillary lymph node dissection could be avoided.

Conditions
RECRUITING
Magnetic Resonance Spectroscopy Studies of Cardiac Muscle Metabolism
Description

The metabolism of the heart provides the chemical energy needed to fuel ongoing normal heart contraction. Magnetic resonance spectroscopy is a technique used in a MRI scanner that can be used to measure and study heart metabolism directly but without blood sampling or obtaining tissue biopsies. One of the hypotheses this study aims to investigate is whether energy metabolism is reduced in heart failure and whether that contributes to the poor heart function.