HealthyNCT00001714
Magnetization Transfer Quantitation and Characterization for Clinical Scanners
An observational study of Healthy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This project will measure magnetization transfer (MT) parameters on normal subjects using two novel approaches. The first is the investigation of asymmetric MT effects with respect to the zero or on-resonance reference point. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1998to Jul 2001
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Normal control between the ages of 18 - 70 years of age who are capable of giving informed consent.
Subjects must not have a condition which would preclude their use for technical development (e.g. paralyzed hemidiaphragm, morbid obesity, claustrophobia, etc.).
Subjects must not have a condition which would 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.
Must not have a contraindication to MR scanning such as surgery that involves metal clips or wires which might be expected to 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); insulin pump.
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
This project will measure magnetization transfer (MT) parameters on normal subjects using two novel approaches. The first is the investigation of asymmetric MT effects with respect to the zero or on-resonance reference point. The technique measures the difference in MT effect between two symmetrically positioned off-resonance MT pulses in the positive and negative frequency ranges. Prior research with this technique in the kidney show a difference in the macromolecular lineshape that correlates to a specific metabolite. The second approach, utilizing a subset of the acquisitions from the first approach, will test newly developed formulation to calculate the macromolecular fraction, or fraction of proton density that accounts for MT. We foresee these measurements may significantly develop our understanding of MT and introduce diagnostic and quantitative tools to study human tissues.
Read the detailed description
This project will measure magnetization transfer (MT) parameters on normal subjects using two novel approaches. The first is the investigation of asymmetric MT effects with respect to the zero or on-resonance reference point. The technique measures the difference in MT effect between two symmetrically positioned off-resonance MT pulses in the positive and negative frequency ranges. Prior research with this technique in the kidney show a difference in the macromolecular lineshape that correlates to a specific metabolite. The second approach, utilizing a subset of the acquisitions from the first approach, will test newly developed formulation to calculate the macromolecular fraction, or fraction of proton density that accounts for MT. We foresee these measurements may significantly develop our understanding of MT and introduce diagnostic and quantitative tools to study human tissue.
- Conditions
- Healthy
- Keywords
- MRI, Macromolecules, Magnetization Transfer, Metabolites, Tissue Characterization, Normal Volunteer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startMar 1998
- Study completionJul 2001
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 HealthyStudies 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
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001714
- Sponsor's protocol ID
- 980084
- Other IDs
- 98-CC-0084
- Status last verified
- Feb 2001
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Bottomley PA, Foster TH, Argersinger RE, Pfeifer LM. A review of normal tissue hydrogen NMR relaxation times and relaxation mechanisms from 1-100 MHz: dependence on tissue type, NMR frequency, temperature, species, excision, and age. Med Phys. 1984 Jul-Aug;11(4):425-48. doi: 10.1118/1.595535.
PubMed 6482839Wolff SD, Balaban RS. Magnetization transfer contrast (MTC) and tissue water proton relaxation in vivo. Magn Reson Med. 1989 Apr;10(1):135-44. doi: 10.1002/mrm.1910100113.
PubMed 2547135Wolff SD, Balaban RS. Magnetization transfer imaging: practical aspects and clinical applications. Radiology. 1994 Sep;192(3):593-9. doi: 10.1148/radiology.192.3.8058919. No abstract available.
PubMed 8058919
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetization Transfer Quantitation and Characterization for Clinical Scanners
- ClinicalTrials.gov ID
- NCT00001714
- Acronym / sponsor ID
- 980084
- Conditions
- Healthy
- Keywords
- MRI, Macromolecules, Magnetization Transfer, Metabolites, Tissue Characterization, Normal Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Mar 1998
- Study completion
- Jul 2001
- First posted
- 10 Dec 2002 (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.
This project will measure magnetization transfer (MT) parameters on normal subjects using two novel approaches. The first is the investigation of asymmetric MT effects with respect to the zero or on-resonance reference point. The technique measures the difference in MT effect between two symmetrically positioned off-resonance MT pulses in the positive and negative frequency ranges. Prior research with this technique in the kidney show a difference in the macromolecular lineshape that correlates to a specific metabolite. The second approach, utilizing a subset of the acquisitions from the first approach, will test newly developed formulation to calculate the macromolecular fraction, or fraction of proton density that accounts for MT. We foresee these measurements may significantly develop our understanding of MT and introduce diagnostic and quantitative tools to study human tissues.
Detailed description
This project will measure magnetization transfer (MT) parameters on normal subjects using two novel approaches. The first is the investigation of asymmetric MT effects with respect to the zero or on-resonance reference point. The technique measures the difference in MT effect between two symmetrically positioned off-resonance MT pulses in the positive and negative frequency ranges. Prior research with this technique in the kidney show a difference in the macromolecular lineshape that correlates to a specific metabolite. The second approach, utilizing a subset of the acquisitions from the first approach, will test newly developed formulation to calculate the macromolecular fraction, or fraction of proton density that accounts for MT. We foresee these measurements may significantly develop our understanding of MT and introduce diagnostic and quantitative tools to study human tissue.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 6482839Bottomley PA, Foster TH, Argersinger RE, Pfeifer LM. A review of normal tissue hydrogen NMR relaxation times and relaxation mechanisms from 1-100 MHz: dependence on tissue type, NMR frequency, temperature, species, excision, and age. Med Phys. 1984 Jul-Aug;11(4):425-48. doi: 10.1118/1.595535.
- Background: PubMed 2547135Wolff SD, Balaban RS. Magnetization transfer contrast (MTC) and tissue water proton relaxation in vivo. Magn Reson Med. 1989 Apr;10(1):135-44. doi: 10.1002/mrm.1910100113.
- Background: PubMed 8058919Wolff SD, Balaban RS. Magnetization transfer imaging: practical aspects and clinical applications. Radiology. 1994 Sep;192(3):593-9. doi: 10.1148/radiology.192.3.8058919. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001714, 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 4 Mar 2008.