Magnetic Resonance Imaging (MRI) Ofl Volunteers
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|ClinicalTrials.gov Identifier: NCT00001711|
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : February 21, 2020
|First Submitted Date||November 3, 1999|
|First Posted Date||November 4, 1999|
|Last Update Posted Date||February 21, 2020|
|Actual Study Start Date||February 6, 1998|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||To develop and optimize new MR techniques for ultimateuse in patient protocols [ Time Frame: End of study ]
To develop and optimize new MR techniques for ultimate use in patient protocols.
|Original Primary Outcome Measures||Not Provided|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Magnetic Resonance Imaging (MRI) Ofl Volunteers|
|Official Title||Volunteer Scanning on MR|
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.
|Detailed Description||Technical evaluation of magnetic resonance imaging and spectroscopy will be performed on subjects who are eligible and willing to volunteer to have a research MRI performed. These studies may involve the intravenous administration of commercially available MR contrast media. Some scans may require inhaled carbogen (95% oxygen and 5% carbon dioxide) and hyperoxia (100% oxygen) 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.|
|Study Design||Observational Model: Other
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||Any subject above the age of 18 who is capable of giving informed consent. This study allows for the enrollment of healthy volunteers as well as volunteers with disease for the purpose of continued technical development in a wide variety of conditions.@@@|
|Study Groups/Cohorts||1/Healthy Volunteers and Patients
Healthy volunteers and patients age 18 and older.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
Any subject above the age of 18 who is capable of giving informed consent.
This study allows for the enrollment of healthy volunteers as well as volunteers with disease for the purpose of continued technical development in a wide variety of conditions.
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.
To assess whether subjects are normal eligible to participate, they will be asked to fill out a questionnaire. 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 pheochromocystoma 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.
To assess whether subjects are eligible to participate in a GBCA study, before undergoing a GBCA imaging study, volunteers will be asked whether or not they have received a MRI with contrast at an outside institution within the last 6 months and have their Clinical Center medical records reviewed. To track exposures to intravenous GBCAs, for each subject we are administrating GBCA, we will maintain a database recording any reports of GBCA administration at an outside institution and the running total of GCBA administration at the Clinical Center. Volunteers who have had exposure to intravenous GBCAs within the last 6 months at an outside institution or the Clinical Center, or reached their maximum of 4 GBCA research imaging studies during their study participation on this protocol, will be excluded from having a contrast enhanced MRI, but will not be excluded from the protocol for non-contrasted MRI studies.
To ensure volunteers who have renal failure do not undergo a GBCA imaging study, all volunteers who will receive Gadolinium based contrast agents will have a serum Creatinine obtained within one week of the MRI examination. All subjects with a calculated eGFR less than or equal to 60 will be excluded from having a contrast enhanced MRI, but will not be excluded from the protocol for non-contrasted MRI studies.
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||980019
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC)|
|Study Sponsor||National Institutes of Health Clinical Center (CC)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||July 10, 2019|