Magnetic Resonance Imaging Contrast AgentsNCT03910114
Gadolinium-Based-Contrast-Agents (GBCA) Enhancement During MR Urography
An observational study of Magnetic Resonance Imaging Contrast Agents, run by Vanderbilt University Medical Center at 2 sites in United States.
Trial summary
Rationale: Dotarem provides superior enhancement characteristics compared to other GBCA in fMRU Specific Aims: Compare enhancement characteristics of Dotarem to other GBCAs in the kidneys used in fMRU Primary Objectives: Review functional analysis curves and data of fMRU studies and determine enhancement… Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Magnetic Resonance Imaging Contrast Agents
- What is being tested?
- Magnevist, Dotarem and Gadovist
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 1990to 1 Apr 2019
- 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 21 years
- All sexes
- Child, Adult
Study population: Pediatric population which obtained MRI/fMRU study
Who may be able to join
- Pediatric population which obtained MRI/fMRU study
Who cannot join
- Bilateral abnormal kidneys
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt Childeen's Hospital
Nashville, Tennessee, 37232
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
About this study
Official title: Contrast Enhancement Characteristics of Gadolinium-Based-Contrast-Agents (GBCA) in Functional MR Urography (fMRU)
Rationale: Dotarem provides superior enhancement characteristics compared to other GBCA in fMRU
Specific Aims: Compare enhancement characteristics of Dotarem to other GBCAs in the kidneys used in fMRU
Primary Objectives: Review functional analysis curves and data of fMRU studies and determine enhancement characteristics in the kidneys of the three GBCAs (Dotarem, Gadovist, Magnevist)
Read the detailed description
A retrospective review will be performed of all functional MRI urography (fMRU) cases at two institutions (Children's Hospital of Philadelphia and Vanderbilt Children's Hospital). Over 1000 studies have been performed between the institutions and the normal studies will be selected based on radiology reports and reviewed to confirm they are normal. The fMRU is performed with Gadolinium based contrast agents (GBCAs), initially was performed with Magnevist, then switched to Gadavist, and most recently converted to Dotarem. The fMRU software for analysis of the functional data provides enhancement curves of the aorta and kidneys. fMRU enhancement curves are generated by drawing regions of interest in the aorta and renal parenchyma and calculating the average signal intensity over time. A comparison of the enhancement curves will be performed of the three GBCAs in the normal pediatric population. The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs. The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained. Additional functional data will be reviewed such as calyceal transit time (CTT) and renal transit time (RTT).
- Being tested
- Magnevist, Dotarem, Gadovist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnevistDrug
GBCA enhancement
DotaremDrug
GBCA enhancement
GadovistDrug
GBCA enhancement
| Study group | Role | What they receive |
|---|---|---|
| Dotarem Enhancement Group | Not described Receives: Drug: Dotarem | |
| Gadovist Enhancement Group | Not described Receives: Drug: Gadovist | |
| Magnevist Enhancement Group | Not described Receives: Drug: Magnevist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dotarem TTP
The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.
Measured: 1 hour
Gadovist TTP
The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.
Measured: 1 hour
Magnevist TTP
The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.
Measured: 1 hour
Dotarem Time of Enhancement Intensity
The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained.
Measured: 1 hour
Gadovist Time of Enhancement Intensity Time of Enhancement Intensity for Gadovist
The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained.
Measured: 1 hour
Magnevist Time of Enhancement Intensity Time of Enhancement Intensity for Gadovist
The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 Jul 1990
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance Imaging Contrast AgentsStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Guerbet, Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, Aashim Bhatia, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910114
- Sponsor's protocol ID
- I002672
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 10 Apr 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhancement Characteristics of Gadolinium-Based-Contrast-Agents (GBCA) in Functional MR Urography (fMRU)
- ClinicalTrials.gov ID
- NCT03910114
- Acronym / sponsor ID
- I002672
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Guerbet, Children's Hospital of Philadelphia
- Study start
- 1 Jul 1990 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 10 Apr 2019 (actual)
- 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.
Rationale: Dotarem provides superior enhancement characteristics compared to other GBCA in fMRU
Specific Aims: Compare enhancement characteristics of Dotarem to other GBCAs in the kidneys used in fMRU
Primary Objectives: Review functional analysis curves and data of fMRU studies and determine enhancement characteristics in the kidneys of the three GBCAs (Dotarem, Gadovist, Magnevist)
Detailed description
A retrospective review will be performed of all functional MRI urography (fMRU) cases at two institutions (Children's Hospital of Philadelphia and Vanderbilt Children's Hospital). Over 1000 studies have been performed between the institutions and the normal studies will be selected based on radiology reports and reviewed to confirm they are normal. The fMRU is performed with Gadolinium based contrast agents (GBCAs), initially was performed with Magnevist, then switched to Gadavist, and most recently converted to Dotarem. The fMRU software for analysis of the functional data provides enhancement curves of the aorta and kidneys. fMRU enhancement curves are generated by drawing regions of interest in the aorta and renal parenchyma and calculating the average signal intensity over time. A comparison of the enhancement curves will be performed of the three GBCAs in the normal pediatric population. The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs. The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained. Additional functional data will be reviewed such as calyceal transit time (CTT) and renal transit time (RTT).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dotarem Enhancement Group | – | Drug: Dotarem |
| Gadovist Enhancement Group | – | Drug: Gadovist |
| Magnevist Enhancement Group | – | Drug: Magnevist |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Pediatric population which obtained MRI/fMRU study
Key inclusion criteria (1 listed)
- Pediatric population which obtained MRI/fMRU study
Key exclusion criteria (1 listed)
- Bilateral abnormal kidneys
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 |
|---|---|---|
| MagnevistGBCA enhancement | Drug | Magnevist Enhancement Group |
| DotaremGBCA enhancement | Drug | Dotarem Enhancement Group |
| GadovistGBCA enhancement | Drug | Gadovist Enhancement Group |
Primary outcome
Dotarem TTP
Time frame: 1 hour
The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.
Gadovist TTP
Time frame: 1 hour
The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.
Magnevist TTP
Time frame: 1 hour
The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.
Dotarem Time of Enhancement Intensity
Time frame: 1 hour
The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained.
Gadovist Time of Enhancement Intensity Time of Enhancement Intensity for Gadovist
Time frame: 1 hour
The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained.
Magnevist Time of Enhancement Intensity Time of Enhancement Intensity for Gadovist
Time frame: 1 hour
The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained.
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 10 Apr 2019.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Magnetic Resonance Imaging Contrast Agents, run by Vanderbilt University Medical Center at 2 sites 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 1 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 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Dotarem TTP (time frame: 1 hour). The study lists 6 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 10 Apr 2019.