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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 3, 1999 | ||||||||
| Last Updated Date | October 24, 2009 | ||||||||
| Start Date ICMJE | September 1999 | ||||||||
| Estimated Primary Completion Date | September 2002 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE |
To determine the response rate and duration of response to intra-hepatic infusion of melphalan with subsequent venous hemofiltration in patients with primary and metastatic hepatic malignancies. | ||||||||
| Change History | Complete list of historical versions of study NCT00001844 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE |
To determine the patterns of recurrence following percutaneous hepatic perfusion (PHP) with melphalan. | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of New Magnetic Resonance Methods | ||||||||
| Official Title ICMJE | Functional and Metabolic Imaging Using Magnetic Resonance at 3.0 Tesla | ||||||||
| Brief Summary | This study will evaluate new magnetic resonance imaging (MRI ) methods using a MRI machine more powerful than those in most hospitals. MRI is a diagnostic tool that uses a large magnet and radio waves to produce images of the human body. It can also provide information about brain chemistry and physiology. This study will use the new MRI hardware and methods to measure blood flow and metabolism in regions of the brain during simple tasks, such as listening to tones or watching flashing checkerboards. Healthy normal volunteers will undergo MRI scanning. For this procedure, the person lies on a stretcher that is moved into a MRI machine, which produces a strong magnetic field. A special lightweight coil is placed on the person's head to obtain better pictures. The scan time ranges from 20 minutes to 2 hours, with the average scan lasting between 45 and 90 minutes. Some persons will be asked to have a contrast agent called gadolinium DTPA injected into their arm through an intravenous catheter (a thin tube placed in a vein). This substance improves scan pictures and is often used in routine MRI brain scans. During the MRI, the person may be asked to perform simple tasks, such as listening to tones or watching a screen, tapping fingers or moving a hand. More complex tasks may require thinking about tones or pictures and responding to them by pressing buttons. The images produced in this study will be compared with those produced using standard MRI. The results will be used to develop improved imaging methods for better patient care and research. |
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| Detailed Description | Technical advances in Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) has provided researchers with the opportunity to study functional and metabolic changes of the central nervous system (CNS) in both healthy controls and individuals with neurological diseases in response to sensory, motor or cognitive stimulation. While MRI is in common usage in radiology departments and clinics MRI and MRS techniques and hardware are continually being upgraded and designed for Functional Magnetic Resonance Imaging (fMRI) and Magnetic Resonance Spectroscopic Imaging of the CNS at 3.0 Tesla. We will evaluate new sequences on volunteers and for potential use in patients with CNS pathology. These studies are required in order to develop and implement new imaging techniques for research and clinical applications. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE | Healthy | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 500 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | September 2002 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
EXCLUSION CRITERIA:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00001844 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 990163, 99-CC-0163 | ||||||||
| Study Sponsor ICMJE | National Institutes of Health Clinical Center (CC) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | October 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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