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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 3, 1999 | ||||||||
| Last Updated Date | September 16, 2009 | ||||||||
| Start Date ICMJE | October 1997 | ||||||||
| Estimated Primary Completion Date | October 2001 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00001711 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Magnetic Resonance Imaging (MRI) of Normal Volunteers | ||||||||
| Official Title ICMJE | Normal Volunteer Scanning on MR | ||||||||
| Brief Summary | Magnetic resonance is an imaging technique that uses magnetic fields and radio waves to create images of the body. The technology used in magnetic resonance imaging continues to improve. Advancements in magnetic resonance imaging (MRI) requires researchers to study new techniques in normal volunteers in order to understand how to use them in patients with diseases. In this study researchers plan to do a variety of diagnostic tests including magnetic resonance imaging on normal volunteers. The studies may involve injections of contrast media, substances injected into the blood of participant that improves the image created by the MRI scanner. The study is not expected to benefit the participants. However, information gathered from the study may be used to improve diagnostic techniques and develop new research studies. ... |
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| Detailed Description | Technical evaluation of magnetic resonance imaging and spectroscopy will be performed on normal volunteers. These studies may involve the intravenous administration of commercially available MR contrast media, glucagon or secretin, or an FDA approved microbubble contrast agent, Optison. Some scans may require gastrointestinal contrast such as water or dilute gadolinium or barium. We also use inhaled carbogen as a contrast media. The results will be used to evaluate the performance of various pulse sequences, gradient coils, and rf coils on human subjects and will provide essential ground work for specific patient protocols. |
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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 | 99999999 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | October 2001 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Any normal volunteer above the age of 18 who is capable of giving informed consent. EXCLUSION CRITERIA: A subject will be excluded if he/she has a contraindication to MR scanning implanted metal clips or wires of the type which may concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field. Examples include: aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, cochlear implant, ocular foreign body (e.g., metal shavings), any implanted device (pumps, infusion devices, etc), shrapnel injuries. For studies involving the use or Optison (microbubble contrast agent), subjects will be excluded if they have severe liver or lung disease, congenital heart defects, history of pulmonary emboli, or known or suspected hyper-sensitivity (allergic reaction) to blood, blood products or albumin. For studies involving the injection of Gadolinium based contrast a serum Creatinine obtained within one week of the MRI examination. All subjects with a calculated eGFR less than 60 will be excluded from having a contrast enhanced MRI, but will not be excluded from the protocol for non contrasted MRI studies. Subjects will be excluded if it is deemed that they have a condition which would preclude their use for technical development (e.g., paralyzed hemidiaphragm, morbid obesity, claustrophobia, etc.) or present unnecessary risks (e.g. pregnancy, surgery of uncertain type, symptoms of pheochromocytoma or insulinoma, etc.) Lactating women and subjects with hemoglobinopathies, asthma, or renal or hepatic disease will be excluded from studies involving the administration of contrast agents. |
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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 | NCT00001711 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 980019, 98-CC-0019 | ||||||||
| 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 | August 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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