Abdominal Organs - LipodystrophyNCT00001219
Comparing Magnetic Resonance Imaging/Spectroscopy Techniques
An observational study of Abdominal Organs - Lipodystrophy and Tumors, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) are diagnostic tests that allow researchers to look at different chemical properties of tissue. Magnetic resonance imaging and spectroscopy studies can be used to gather or evaluate information about various aspects of patient s bodies or to… Read more about this study
- Who is it for?
- Ages Up to 99 years
- Conditions the study is for
- Abdominal Organs - Lipodystrophy, Tumors
- How many people
- 49,946 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 1987to 3 Jun 2020
- 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 Up to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who by virtue of the NIH protocol in which they are enrolled who qualify for MRI in the Clinical Center, are eligible to participate if (1) Stable for MRI (2) Able to understand the consent so that consent/assent can be obtained
Who may be able to join
- All patients undergoing MRI in the Clinical Center.
- Patients must be able to provide informed consents.
Who cannot join
- Contraindications to MRI.
- Inability to understand consent form or consent process and the absence of a suitable guardian.
- Adults who are or may not be able to consent
- Patients in whom the scan must be performed quickly, i.e. those patients under anesthesia, anxious patients, those requiring emergency medical care, or others in which it is deemed inappropriate to prolong a study.
- Refusal to Participate.
- Pregnant women and fetuses
- Neonates
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Magnetic Resonance Imaging at 1.5 and 3.0 Tesla
Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) are diagnostic tests that allow researchers to look at different chemical properties of tissue. Magnetic resonance imaging and spectroscopy studies can be used to gather or evaluate information about various aspects of patient s bodies or to monitor changes in the biochemistry and physiology of patient s bodies.
Unlike other diagnostic techniques (CT scan and PET scan) MRI and MRS do not use ionizing radiation. Some studies have shown that MRI is more effective at distinguishing normal parts of the anatomy from abnormal anatomy, especially in the brain. MRI has become the diagnostic test of choice for evaluating patient with multiple sclerosis.
The purpose of this study is to evaluate normal volunteers and patients with a variety of diseases with magnetic resonance imaging. Researchers will attempt different magnetic resonance imaging methods and techniques as well as different levels of magnetic strength.
Read the detailed description
Background:
MRI is a constantly evolving imaging modality. Pulse sequences are often modified to improve their performance. However, many of these changes have not yet been approved by the FDA and therefore, are not considered standard of care. Some of these sequences require the use of new types of imaging coils, which are also investigational.
Objectives:
The major purpose of this protocol is to inform patients undergoing MR scans in the Clinical Center that they be scanned with MRI sequences and/or coils which may or may not be FDA approved and to get the patient s consent for this. This is not a formal research study since specific disease entities and specific pulse sequences are not studied in a systematic way. Rather, the purpose is to give NIH patients access to gradual improvements in MR technology that would otherwise not be available to them.
Eligibility:
All patients who, by virtue of the NIH protocol in which they are enrolled, qualify for MRI will be eligible for participation in this protocol.
Design:
Up to 99,999 participants will be enrolled in this study.
- Conditions
- Abdominal Organs - Lipodystrophy, Tumors
- Keywords
- MR Technology, Pulse Sequences, FDA Approved, MRI Sequences, Investigational Coils
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing MRI in the Clinical Center | All patients who, by virtue of the NIH protocol in which they are enrolled, who qualify for MRI will be eligible for participation in this protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of new sequences
clinically meaningful pulse sequence improvements
Measured: 10 scan comparison
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 start18 Jun 1987
- Primary completion3 Jun 2020
- Study completion3 Jun 2020
Why it stopped: protocol has not been used for many years and has outlived it utility
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 Abdominal Organs - LipodystrophyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49,946 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
- NCT00001219
- Sponsor's protocol ID
- 870091
- Other IDs
- 87-CC-0091
- Status last verified
- Jun 2020
- First submitted
- 3 Nov 1999
- Last updated
- 5 Jun 2020
- Results posted
- No
Publications
Frank JA, Dwyer AJ, Doppman JL. Nuclear magnetic resonance imaging in oncology. Important Adv Oncol. 1987:133-74.
PubMed 3331379Roschmann P, Tischler R. Surface coil proton MR imaging at 2 T. Radiology. 1986 Oct;161(1):251-5. doi: 10.1148/radiology.161.1.3763875.
PubMed 3763875Kim EE, Pjura G, Lowry P, Verani R, Sandler C, Flechner S, Kahan B. Cyclosporin-A nephrotoxicity and acute cellular rejection in renal transplant recipients: correlation between radionuclide and histologic findings. Radiology. 1986 May;159(2):443-6. doi: 10.1148/radiology.159.2.3515421.
PubMed 3515421
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging at 1.5 and 3.0 Tesla
- ClinicalTrials.gov ID
- NCT00001219
- Acronym / sponsor ID
- 870091
- Conditions
- Abdominal Organs - Lipodystrophy, Tumors
- Keywords
- MR Technology, Pulse Sequences, FDA Approved, MRI Sequences, Investigational Coils
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: protocol has not been used for many years and has outlived it utility
- Enrolment
- 49,946 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 18 Jun 1987 (actual)
- Primary completion
- 3 Jun 2020 (actual)
- Study completion
- 3 Jun 2020 (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 imaging (MRI) and magnetic resonance spectroscopy (MRS) are diagnostic tests that allow researchers to look at different chemical properties of tissue. Magnetic resonance imaging and spectroscopy studies can be used to gather or evaluate information about various aspects of patient s bodies or to monitor changes in the biochemistry and physiology of patient s bodies.
Unlike other diagnostic techniques (CT scan and PET scan) MRI and MRS do not use ionizing radiation. Some studies have shown that MRI is more effective at distinguishing normal parts of the anatomy from abnormal anatomy, especially in the brain. MRI has become the diagnostic test of choice for evaluating patient with multiple sclerosis.
The purpose of this study is to evaluate normal volunteers and patients with a variety of diseases with magnetic resonance imaging. Researchers will attempt different magnetic resonance imaging methods and techniques as well as different levels of magnetic strength.
Detailed description
Background:
MRI is a constantly evolving imaging modality. Pulse sequences are often modified to improve their performance. However, many of these changes have not yet been approved by the FDA and therefore, are not considered standard of care. Some of these sequences require the use of new types of imaging coils, which are also investigational.
Objectives:
The major purpose of this protocol is to inform patients undergoing MR scans in the Clinical Center that they be scanned with MRI sequences and/or coils which may or may not be FDA approved and to get the patient s consent for this. This is not a formal research study since specific disease entities and specific pulse sequences are not studied in a systematic way. Rather, the purpose is to give NIH patients access to gradual improvements in MR technology that would otherwise not be available to them.
Eligibility:
All patients who, by virtue of the NIH protocol in which they are enrolled, qualify for MRI will be eligible for participation in this protocol.
Design:
Up to 99,999 participants will be enrolled in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing MRI in the Clinical Center | – | –All patients who, by virtue of the NIH protocol in which they are enrolled, who qualify for MRI will be eligible for participation in this protocol. |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who by virtue of the NIH protocol in which they are enrolled who qualify for MRI in the Clinical Center, are eligible to participate if (1) Stable for MRI (2) Able to understand the consent so that consent/assent can be obtained
Key inclusion criteria (2 listed)
- All patients undergoing MRI in the Clinical Center.
- Patients must be able to provide informed consents.
Key exclusion criteria (7 listed)
- Contraindications to MRI.
- Inability to understand consent form or consent process and the absence of a suitable guardian.
- Adults who are or may not be able to consent
- Patients in whom the scan must be performed quickly, i.e. those patients under anesthesia, anxious patients, those requiring emergency medical care, or others in which it is deemed inappropriate to prolong a study.
- Refusal to Participate.
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
Success of new sequences
Time frame: 10 scan comparison
clinically meaningful pulse sequence improvements
Results and safety
The study was stopped early (reason given: protocol has not been used for many years and has outlived it utility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Background: PubMed 3331379Frank JA, Dwyer AJ, Doppman JL. Nuclear magnetic resonance imaging in oncology. Important Adv Oncol. 1987:133-74.
- Background: PubMed 3763875Roschmann P, Tischler R. Surface coil proton MR imaging at 2 T. Radiology. 1986 Oct;161(1):251-5. doi: 10.1148/radiology.161.1.3763875.
- Background: PubMed 3515421Kim EE, Pjura G, Lowry P, Verani R, Sandler C, Flechner S, Kahan B. Cyclosporin-A nephrotoxicity and acute cellular rejection in renal transplant recipients: correlation between radionuclide and histologic findings. Radiology. 1986 May;159(2):443-6. doi: 10.1148/radiology.159.2.3515421.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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 Abdominal Organs - Lipodystrophy and Tumors, 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 5 Jun 2020. 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 was stopped early (reason given: protocol has not been used for many years and has outlived it utility). Results are not available in the source record.
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?
Success of new sequences (time frame: 10 scan comparison). 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 NCT00001219, 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 5 Jun 2020.