Trial Outcomes & Findings for DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in Patients With Abdominal or Lower Limb Arterial Diseases (NCT NCT00955617)

Results Overview

Number of images quoted with excellent and more than adequate quality in each group. Image quality will be assessed on a 5-point scale: 1. Excellent 2. More than adequate 3. Adequate 4. Less than adequate 5. Non-diagnostic Each image is analysed by 4 readers.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

MRA examination

Results posted on

2012-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Dotarem Then Gadovist Cross over administration, patient received first Dotarem enhanced-MRA (MRA1) and then Gadovist enhanced-MRA (MRA2)	Gadovist Then Dotarem Cross over administration: patient received first Gadovist enhanced-MRA (MRA1) and then Dotarem enhanced-MRA (MRA2)
First MRA (Between Day0 and Day21) STARTED	10	10
First MRA (Between Day0 and Day21) COMPLETED	10	10
First MRA (Between Day0 and Day21) NOT COMPLETED	0	0
Second MRA (Between Day 1 and Day 51) STARTED	10	10
Second MRA (Between Day 1 and Day 51) COMPLETED	7	7
Second MRA (Between Day 1 and Day 51) NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Dotarem Then Gadovist Cross over administration, patient received first Dotarem enhanced-MRA (MRA1) and then Gadovist enhanced-MRA (MRA2)	Gadovist Then Dotarem Cross over administration: patient received first Gadovist enhanced-MRA (MRA1) and then Dotarem enhanced-MRA (MRA2)
Second MRA (Between Day 1 and Day 51) Withdrawal by Subject	2	1
Second MRA (Between Day 1 and Day 51) Lost to Follow-up	0	1
Second MRA (Between Day 1 and Day 51) technical incident	0	1
Second MRA (Between Day 1 and Day 51) conventional angiography	1	0

Baseline Characteristics

DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in Patients With Abdominal or Lower Limb Arterial Diseases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=20 Participants All Patients received both product Dotarem and Gadovist during 2 enhanced-MRA. Demographic analysis was performed on the global population.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age Continuous	61.5 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment Germany	20 participants n=5 Participants

PRIMARY outcome

Timeframe: MRA examination

Population: descriptive and pilot study, no number of participants calculation performed

Number of images quoted with excellent and more than adequate quality in each group. Image quality will be assessed on a 5-point scale: 1. Excellent 2. More than adequate 3. Adequate 4. Less than adequate 5. Non-diagnostic Each image is analysed by 4 readers.

Outcome measures

Outcome measures
Measure	Dotarem n=56 cases (4 evaluations per image) Evaluation performed on Dotarem enhanced MRA images	Gadovist n=56 cases (4 evaluations per image) Evaluation performed on Gadovist enhanced MRA images
Overall Image Quality of MRA Images	56 Images	48 Images

SECONDARY outcome

Timeframe: MRA examination

Population: Descriptive study - No calculation

Number of High/Excellent diagnostic confidence. Level of diagnostic confidence assessed on a 5-point scale by patient: nil, poor, moderate, high, excellent. Each image is analysed by 4 readers.

Outcome measures

Outcome measures
Measure	Dotarem n=56 cases (4 evaluations per image) Evaluation performed on Dotarem enhanced MRA images	Gadovist n=56 cases (4 evaluations per image) Evaluation performed on Gadovist enhanced MRA images
Diagnostic Confidence	55 Images	50 Images

SECONDARY outcome

Timeframe: MRA examination

Signal to Noise ratio (SNR): SNR = SIa /NO SIa is the signal intensity measured in the ROI positioned in the artery. NO is noise defined as the standard deviation (SD) of signal intensity measured in the subtraction image (of the two non-enhanced scans) at the same location as the arterial ROI is to be measured.

Outcome measures

Outcome measures
Measure	Dotarem n=14 Participants Evaluation performed on Dotarem enhanced MRA images	Gadovist n=14 Participants Evaluation performed on Gadovist enhanced MRA images
Signal Intensity	23 Ratio Standard Deviation 10	26 Ratio Standard Deviation 11

Adverse Events

Dotarem MRA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Gadovist MRA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Emilie Huchet

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: LTE60