Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 3 for:    John Butman | United States

Magnetic Resonance Imaging (MRI) Ofl Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00001711
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Tracking Information
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
 (submitted: July 19, 2019)
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
Change History
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
 
Descriptive Information
Brief Title Magnetic Resonance Imaging (MRI) Ofl Volunteers
Official Title 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.

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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen 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.@@@
Condition
  • Healthy Volunteers
  • Patients
Intervention Not Provided
Study Groups/Cohorts 1/Healthy Volunteers and Patients
Healthy volunteers and patients age 18 and older.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 24, 2009)
99999999
Original Enrollment
 (submitted: June 23, 2005)
1000
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • INCLUSION CRITERIA:

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.

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:

  1. Aneurysm clip
  2. Implanted neural stimulator
  3. Implanted cardiac pacemaker or autodefibrillator
  4. Cochlear implant
  5. Ocular foreign body (e.g., metal shavings)
  6. Any implanted device (pumps, infusion devices, etc)
  7. Shrapnel injuries
  8. All employees/staff supervised by the Principal Investigator or an Associate Investigator are excluded from participation.

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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Tracy L Cropper, R.N. (301) 402-6132 tcropper@cc.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00001711
Other Study ID Numbers 980019
98-CC-0019
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)
Collaborators Not Provided
Investigators
Principal Investigator: John A Butman, M.D. National Institutes of Health Clinical Center (CC)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date July 10, 2019