Healthy VolunteersNCT00001711
Magnetic Resonance Imaging (MRI) Ofl Volunteers
An observational study of Healthy Volunteers and Patients, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Patients
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 1,229 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 1998to 26 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.@@@
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 12Show fewer
- Any implanted device (pumps, infusion devices, etc)
- Shrapnel injuries
- 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 NIH RADIS MRI Safety questionnaire. Subjects will be excluded if it is deemed that they have a condition which would preclude their use for study related MRI (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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read the 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 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.
- Conditions
- Healthy Volunteers, Patients
- Being tested
- MRI
- Keywords
- Magnetic Resonance Imaging, Gadolinium, MRA, Diagnostic Tool, Contrast, Natural History, Normal Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
scan of healthy volunteers.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers and Patients | Healthy volunteers and patients age 18 and older. Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop and optimize new MR techniques for ultimate use in patient protocols
develop and optimize new MR techniques for ultimate use in patient protocols.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start6 Feb 1998
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,229 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- John A Butman, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001711
- Sponsor's protocol ID
- 980019
- Other IDs
- 98-CC-0019
- Status last verified
- Sep 2024
- First submitted
- 3 Nov 1999
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: .we are working on deciding if we will share IPDs.
Publications
Choyke PL, Walther MM, Wagner JR, Rayford W, Lyne JC, Linehan WM. Renal cancer: preoperative evaluation with dual-phase three-dimensional MR angiography. Radiology. 1997 Dec;205(3):767-71. doi: 10.1148/radiology.205.3.9393533.
PubMed 9393533Niendorf HP, Dinger JC, Haustein J, Cornelius I, Alhassan A, Clauss W. Tolerance data of Gd-DTPA: a review. Eur J Radiol. 1991 Jul-Aug;13(1):15-20. doi: 10.1016/0720-048x(91)90049-2.
PubMed 1889423Frank JA, Mattay VS, Duyn J, Sobering G, Barrios FA, Zigun J, Sexton R, Kwok P, Woo J, Moonen C, et al. Measurement of relative cerebral blood volume changes with visual stimulation by 'double-dose' gadopentetate-dimeglumine-enhanced dynamic magnetic resonance imaging. Invest Radiol. 1994 Jun;29 Suppl 2:S157-60. doi: 10.1097/00004424-199406001-00052. No abstract available.
PubMed 7928216
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volunteer Scanning on MR
- ClinicalTrials.gov ID
- NCT00001711
- Acronym / sponsor ID
- 980019
- Conditions
- Healthy Volunteers, Patients
- Keywords
- Magnetic Resonance Imaging, Gadolinium, MRA, Diagnostic Tool, Contrast, Natural History, Normal Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,229 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 6 Feb 1998 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers and Patients | – | Procedure: MRIHealthy volunteers and patients age 18 and older. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.@@@
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIscan of healthy volunteers. | Procedure or surgery | Healthy Volunteers and Patients |
Primary outcome
To develop and optimize new MR techniques for ultimate use in patient protocols
Time frame: End of study
develop and optimize new MR techniques for ultimate use in patient protocols.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 9393533Choyke PL, Walther MM, Wagner JR, Rayford W, Lyne JC, Linehan WM. Renal cancer: preoperative evaluation with dual-phase three-dimensional MR angiography. Radiology. 1997 Dec;205(3):767-71. doi: 10.1148/radiology.205.3.9393533.
- Background: PubMed 1889423Niendorf HP, Dinger JC, Haustein J, Cornelius I, Alhassan A, Clauss W. Tolerance data of Gd-DTPA: a review. Eur J Radiol. 1991 Jul-Aug;13(1):15-20. doi: 10.1016/0720-048x(91)90049-2.
- Background: PubMed 7928216Frank JA, Mattay VS, Duyn J, Sobering G, Barrios FA, Zigun J, Sexton R, Kwok P, Woo J, Moonen C, et al. Measurement of relative cerebral blood volume changes with visual stimulation by 'double-dose' gadopentetate-dimeglumine-enhanced dynamic magnetic resonance imaging. Invest Radiol. 1994 Jun;29 Suppl 2:S157-60. doi: 10.1097/00004424-199406001-00052. No abstract available.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. .we are working on deciding if we will share IPDs.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Butman, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers and Patients, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To develop and optimize new MR techniques for ultimate use in patient protocols (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001711, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.