Angiography, Digital SubtractionPhase 4NCT00154648
CE-MRA Using Gadovist in Comparison to IA DSA Using Ultravist
A Phase 4 study testing CE-MRA in people with Angiography, Digital Subtraction and Magnetic Resonance Angiography, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced magnetic resonance angiography (CE-MRA) of the arteries. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Angiography, Digital Subtraction, Magnetic Resonance Angiography
- What is being tested?
- CE-MRA
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2005to not given
- Phase
- Phase 4
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With suspected or known disease of the arteries
- Scheduled for an IA DSA/cut film angiography of the arteries in a period of less than 7 days prior to or after the study period and has completed delineation and documentation of all vessels.
- Willing and able to continue study participation. This includes the administration of Gadovist® 1.0 and completion of all procedures required by the study protocol
- Patient is between 20 and 75 years of age
- Fully informed and has signed consent in advance
Who cannot join
- Patient is clinically unstable or his/her clinical course during the 72 hour safety observation period was unpredictable
- Patient with renal failure
- Woman who is pregnant or of childbearing potential without having had a negative pregnancy test prior to enrollment (within 72 hours prior to CE-MRA)
- Lactating woman
- Patient with any contraindication to magnetic resonance imaging (MRI) examination and IA DSA.
- Patient receives any investigational drug within 30 days prior to study entry or is planned to receive any other investigational drug during the safety follow-up (72 hours after CE-MRA).
Show all 9Show fewer
- Patient is scheduled for surgery or other interventions within the 72 hours after the CE-MRA/IA DSA or had any such procedure within 48 hours prior to the study CE-MRA/IA DSA.
- Hypersensitivity to gadobutrol products
- Patient has previously entered this study
Trial locations and contacts
1 site in 1 country.
Hon-Man Liu, MD contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Hon-Man Liu, MD, 23123456 ext. 2570
Hon-Man Liu, MD
About this study
Official title: An Open, Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) Study of Arteries Using Gadovist 1.0 in Comparison to Intra-Arterial Digital Subtraction Angiography (IA DSA) Using Ultravist
This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced magnetic resonance angiography (CE-MRA) of the arteries.
Read the detailed description
This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced Magnetic Resonance Angiography (CE-MRA) of arteries (specified vessel segments) by analyzing the rate of agreement, image quality, and diagnostic confidence between a CE-MRA based diagnosis and the diagnosis achieved from the comparator procedure IA DSA using Ultravist.
- Being tested
- CE-MRA
- Keywords
- MRA, DSA, gadovist, angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CE-MRAProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of agreement
Image quality
Diagnostic confidence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angiography, Digital SubtractionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hon-Man Liu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154648
- Sponsor's protocol ID
- 0941540200
- Status last verified
- Jun 2005
- First submitted
- 8 Sep 2005
- Last updated
- 5 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) Study of Arteries Using Gadovist 1.0 in Comparison to Intra-Arterial Digital Subtraction Angiography (IA DSA) Using Ultravist
- ClinicalTrials.gov ID
- NCT00154648
- Acronym / sponsor ID
- 0941540200
- Keywords
- MRA, DSA, gadovist, angiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2005
- First posted
- 12 Sep 2005 (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 trial is to show the diagnostic efficacy of Gadovist for contrast enhanced magnetic resonance angiography (CE-MRA) of the arteries.
Detailed description
This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced Magnetic Resonance Angiography (CE-MRA) of arteries (specified vessel segments) by analyzing the rate of agreement, image quality, and diagnostic confidence between a CE-MRA based diagnosis and the diagnosis achieved from the comparator procedure IA DSA using Ultravist.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- With suspected or known disease of the arteries
- Scheduled for an IA DSA/cut film angiography of the arteries in a period of less than 7 days prior to or after the study period and has completed delineation and documentation of all vessels.
- Willing and able to continue study participation. This includes the administration of Gadovist® 1.0 and completion of all procedures required by the study protocol
- Patient is between 20 and 75 years of age
- Fully informed and has signed consent in advance
Key exclusion criteria (9 listed)
- Patient is clinically unstable or his/her clinical course during the 72 hour safety observation period was unpredictable
- Patient with renal failure
- Woman who is pregnant or of childbearing potential without having had a negative pregnancy test prior to enrollment (within 72 hours prior to CE-MRA)
- Lactating woman
- Patient with any contraindication to magnetic resonance imaging (MRI) examination and IA DSA.
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 |
|---|---|---|
| CE-MRA | Procedure or surgery | – |
Primary outcome
Rate of agreement
Image quality
Diagnostic confidence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2007.
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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.
Hon-Man Liu, MD contact
Hon-Man Liu, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CE-MRA in people with Angiography, Digital Subtraction and Magnetic Resonance Angiography, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 5 Jun 2007. 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 Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hon-Man Liu, MD (23123456 ext. 2570), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of agreement. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2007.