Trial Outcomes & Findings for Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF) (NCT NCT00980681)

NCT ID: NCT00980681

Last Updated: 2016-05-26

Results Overview

For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

13 participants

Primary outcome timeframe

1 to 7 days

Results posted on

2016-05-26

Participant Flow

The recruitment started in Sept 2009 and stopped in February 2010. Radiology departments from hospital or private practices were participating.

Out of the 13 enrolled patients, three did not receive treatment, mainly due to the Sponsor decision to interrupt the study

Participant milestones

Participant milestones
Measure	TOF Followed by Dotarem-enhanced MRA Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg).
TOF MRA STARTED	10
TOF MRA COMPLETED	10
TOF MRA NOT COMPLETED	0
Dotarem MRA STARTED	10
Dotarem MRA COMPLETED	10
Dotarem MRA NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TOF Followed by Dotarem-enhanced MRA n=13 Participants Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg).
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants
Age, Continuous	59 years STANDARD_DEVIATION 16 • n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Region of Enrollment United States	7 participants n=93 Participants
Region of Enrollment Canada	6 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 to 7 days

For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared

Outcome measures

Outcome measures
Measure	Dotarem-enhanced MRA n=10 Participants Patients benefiting from an MRA after administration with Dotarem	Time-Of-Flight MRA n=10 Participants Patients benefiting from an MRA with no injection of contrast medium
Percent of Non Assessable Renal Artery Segments	25 percentage of non-assessable segments	20 percentage of non-assessable segments

Adverse Events

Dotarem

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Time Of Flight

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dotarem n=10 participants at risk Each subject will receive one injection of Dotarem 0.2ml/kg. Dotarem: Each subject will receive one injection of Dotarem 0.2ml/kg	Time Of Flight n=10 participants at risk Each subject will undergo a TOF Magnetic Resonance Angiography Time of Flight: Each subject will undergo a TOF MRA
General disorders Injection site pain	20.0% 2/10 • Number of events 2	0.00% 0/10
General disorders Injection site inflammation	10.0% 1/10 • Number of events 1	0.00% 0/10
Gastrointestinal disorders Abdominal pain	10.0% 1/10 • Number of events 1	0.00% 0/10
Gastrointestinal disorders Diarrhea	10.0% 1/10 • Number of events 1	0.00% 0/10

Additional Information

Pierre Desche, MD, Head of Clinical and Regulatory Affairs

Guerbet

Phone: +33 1 45 91 50 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60