Magnetic Resonance ImagingPhase 3NCT00937391
Contrast-enhanced MRI in Children 2 Months to <2 Years
A Phase 3 study testing Gadopentetate dimeglumine (Magnevist, BAY86-6661) in people with Magnetic Resonance Imaging, run by Bayer at 13 sites in 2 countries.
Trial summary
The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist in children 2 months to < 2 years of age Read more about this study
- Who is it for?
- Ages 2 to 23 months
- Conditions the study is for
- Magnetic Resonance Imaging
- What is being tested?
- Gadopentetate dimeglumine (Magnevist, BAY86-6661)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Jan 2010to Sep 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 2 months to < 2 years (23 months)
- Participants (male/female) who are scheduled to undergo gadolinium-enhanced MRI
- Able to comply with the study procedures
Who cannot join
- Clinical unstable participants (eg, intensive care unit)
- Renal Insufficiency
- Participants undergoing chemotherapy </= 48 hours prior to and up to 24 hours after the administration of Magnevist.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States9 sites
Study site
Akron, Ohio, 44308
Study site
Aurora, Colorado, 80045
Study site
Chicago, Illinois, 60614
Study site
Hershey, Pennsylvania, 17033
Study site
Houston, Texas, 77030
Study site
Iowa City, Iowa, 52242
Study site
Kansas City, Missouri, 64108-9898
Study site
San Diego, California, 92123
Study site
St Louis, Missouri, 63110
Germany4 sites
Study site
Dresden, Saxony, 01307
Study site
Halle, Saxony-Anhalt, 06120
Study site
Jena, Thuringia, 07740
Study site
Kiel, Schleswig-Holstein, 24105
About this study
Official title: Open-label, Multi-center, Two-stage, Age Stratified, Pharmacokinetic, Safety, and Efficacy Study in Children 2 Months to < 2 Years of Age Undergoing Magnevist Injection Enhanced MRI
The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist in children 2 months to < 2 years of age
Read the detailed description
Safety issues are addressed in the AE section
- Conditions
- Magnetic Resonance Imaging
- Being tested
- Gadopentetate dimeglumine (Magnevist, BAY86-6661)
- Keywords
- MRI agents, Magnevist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadopentetate dimeglumine (Magnevist, BAY86-6661)Drug
For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
| Study group | Role | What they receive |
|---|---|---|
| Gadopentetate dimeglumine (Magnevist, BAY86-6661) | Experimental | For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)). Receives: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-6661) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)
A clinical judgment by the open-label Clinical Investigators (CIs) as to whether ("yes") or not ("no") the CI could make a diagnosis from the image.
Measured: Within 5 minutes after injection
Dose Determined by Blinded Readers to be Superior for Diagnosis
Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters
Measured: Within 5 minutes after injection
Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
For each participant, the Blinded Reader indicated which dose had better contrast enhancement, better border delineation, clearer internal morphology, and provided more diagnostic information. The dose chosen for 3 or 4 of these variables was the selected dose for that Reader and participant. If each dose was superior on 2 variables, the dose which provided more diagnostic information was selected for that participant. The dose selected for the majority of participants was the dose selected by that Reader; if chosen by 2 or 3 Readers, it was the selected dose.
Measured: Within 5 minutes after injection
PK Analysis - Total Clearance (CL)
Total clearance is the fraction of the volume of distribution (Vd) which is completely purified per unit of time and depends also on the plasma half-life of the drug.
Measured: 20 to 45 min and 4 to 8 hours post injection
PK Analysis - Total Clearance (CL)/Body Weight (BW)
CL/BW = total clearance normalized by BW
Measured: 20 to 45 min and 4 to 8 hours post injection
PK Analysis - Volume of Distribution at Steady State (Vss)
Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.
Measured: 20 to 45 min and 4 to 8 hours post injection
PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW)
Vss/BW = volume of distribution at steady state normalized by body weight
Measured: 20 to 45 min and 4 to 8 hours post injection
PK Analysis - Area Under the Drug Concentration-time Curve (AUC)
AUC = Area under the drug concentration-time curve from administration to infinity
Measured: Samples taken 20 to 45 min and 4 to 8 hours post injection. AUC calculated from time of injection to infinity.
PK Analysis - t 1/2
t 1/2 = termination elimination half-life calculated from the area under the drug concentration-time curve from administration to infinity
Measured: Samples taken at 20 to 45 min and at 4 to 8 hours post injection; t 1/2 calculated from area under the drug concentration-time curve from administration to infinity
Secondary outcomes (20)
Number of Participants With Number of Lesions Detected - Stage 1
BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions.
Measured: Within 5 minutes after injection
Number of Participants With Number of Lesions Detected - Stage 2
BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions.
Measured: Within 5 minutes after injection
Number of Participants With Quality of Lesion Visualization - Stage 1
BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible)
Measured: Within 5 minutes after injection
Number of Participants With Quality of Lesion Visualization - Stage 2
BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible)
Measured: Within 5 minutes after injection
Number of Participants With Quality of Border Delineation - Stage 1
BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set
Measured: Within 5 minutes after injection
Number of Participants With Quality of Border Delineation - Stage 2
BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set
Measured: Within 5 minutes after injection
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1
BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images
Measured: Within 5 minutes after injection
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2
BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images
Measured: Within 5 minutes after injection
Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1
The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator
Measured: Within 5 minutes after injection
Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2
The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator
Measured: Within 5 minutes after injection
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1
Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 1. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator.
Measured: Within 5 minutes after injection
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 2. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator
Measured: Within 5 minutes after injection
Number of Participants With Diagnostic Confidence - Stage 1
The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator
Measured: Within 5 minutes after injection
Number of Participants With Diagnostic Confidence - Stage 2
The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator
Measured: Within 5 minutes after injection
Management Based on Unenhanced Images - Stage 1
For Stage 1 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.
Measured: Within 5 minutes before injection
Management Based on Unenhanced Images - Stage 2
For Stage 2 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.
Measured: Within 5 minutes before injection
Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1
For Stage 1, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for both doses.
Measured: Within 5 minutes after injection
Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2
For Stage 2, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for the optimal efficacious dose determined in Stage 1.
Measured: Within 5 minutes after injection
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1
The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented for both doses in Stage 1
Measured: Within 5 minutes after injection
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2
The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented in Stage 2 for the optimal efficacious dose determined in Stage 1
Measured: Within 5 minutes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by BayerThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937391
- Sponsor's protocol ID
- 91784
- Other IDs
- 2009-013081-17, 312046, 2009
- Status last verified
- Oct 2015
- First submitted
- 10 Jul 2009
- Last updated
- 18 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multi-center, Two-stage, Age Stratified, Pharmacokinetic, Safety, and Efficacy Study in Children 2 Months to < 2 Years of Age Undergoing Magnevist Injection Enhanced MRI
- ClinicalTrials.gov ID
- NCT00937391
- Acronym / sponsor ID
- 91784
- Conditions
- Magnetic Resonance Imaging
- Keywords
- MRI agents, Magnevist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 13 Jul 2009 (estimated)
- Results
- Posted 13 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist in children 2 months to < 2 years of age
Detailed description
Safety issues are addressed in the AE section
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gadopentetate dimeglumine (Magnevist, BAY86-6661) | Experimental | Drug: Gadopentetate dimeglumine (Magnevist, BAY86-6661)For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)). |
Who may qualify
- Ages
- 2 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 2 months to < 2 years (23 months)
- Participants (male/female) who are scheduled to undergo gadolinium-enhanced MRI
- Able to comply with the study procedures
Key exclusion criteria (3 listed)
- Clinical unstable participants (eg, intensive care unit)
- Renal Insufficiency
- Participants undergoing chemotherapy </= 48 hours prior to and up to 24 hours after the administration of Magnevist.
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 |
|---|---|---|
| Gadopentetate dimeglumine (Magnevist, BAY86-6661)For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)). | Drug | Gadopentetate dimeglumine (Magnevist, BAY86-6661) |
Primary outcome
Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)
Time frame: Within 5 minutes after injection
A clinical judgment by the open-label Clinical Investigators (CIs) as to whether ("yes") or not ("no") the CI could make a diagnosis from the image.
Dose Determined by Blinded Readers to be Superior for Diagnosis
Time frame: Within 5 minutes after injection
Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters
Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
Time frame: Within 5 minutes after injection
For each participant, the Blinded Reader indicated which dose had better contrast enhancement, better border delineation, clearer internal morphology, and provided more diagnostic information. The dose chosen for 3 or 4 of these variables was the selected dose for that Reader and participant. If each dose was superior on 2 variables, the dose which provided more diagnostic information was selected for that participant. The dose selected for the majority of participants was the dose selected by that Reader; if chosen by 2 or 3 Readers, it was the selected dose.
PK Analysis - Total Clearance (CL)
Time frame: 20 to 45 min and 4 to 8 hours post injection
Total clearance is the fraction of the volume of distribution (Vd) which is completely purified per unit of time and depends also on the plasma half-life of the drug.
PK Analysis - Total Clearance (CL)/Body Weight (BW)
Time frame: 20 to 45 min and 4 to 8 hours post injection
CL/BW = total clearance normalized by BW
PK Analysis - Volume of Distribution at Steady State (Vss)
Time frame: 20 to 45 min and 4 to 8 hours post injection
Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.
PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW)
Time frame: 20 to 45 min and 4 to 8 hours post injection
Vss/BW = volume of distribution at steady state normalized by body weight
PK Analysis - Area Under the Drug Concentration-time Curve (AUC)
Time frame: Samples taken 20 to 45 min and 4 to 8 hours post injection. AUC calculated from time of injection to infinity.
AUC = Area under the drug concentration-time curve from administration to infinity
PK Analysis - t 1/2
Time frame: Samples taken at 20 to 45 min and at 4 to 8 hours post injection; t 1/2 calculated from area under the drug concentration-time curve from administration to infinity
t 1/2 = termination elimination half-life calculated from the area under the drug concentration-time curve from administration to infinity
20 secondary outcomes
Number of Participants With Number of Lesions Detected - Stage 1
Time frame: Within 5 minutes after injection
Number of Participants With Number of Lesions Detected - Stage 2
Time frame: Within 5 minutes after injection
Number of Participants With Quality of Lesion Visualization - Stage 1
Time frame: Within 5 minutes after injection
Number of Participants With Quality of Lesion Visualization - Stage 2
Time frame: Within 5 minutes after injection
Number of Participants With Quality of Border Delineation - Stage 1
Time frame: Within 5 minutes after injection
Number of Participants With Quality of Border Delineation - Stage 2
Time frame: Within 5 minutes after injection
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1
Time frame: Within 5 minutes after injection
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2
Time frame: Within 5 minutes after injection
Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1
Time frame: Within 5 minutes after injection
Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2
Time frame: Within 5 minutes after injection
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1
Time frame: Within 5 minutes after injection
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
Time frame: Within 5 minutes after injection
Number of Participants With Diagnostic Confidence - Stage 1
Time frame: Within 5 minutes after injection
Number of Participants With Diagnostic Confidence - Stage 2
Time frame: Within 5 minutes after injection
Management Based on Unenhanced Images - Stage 1
Time frame: Within 5 minutes before injection
Management Based on Unenhanced Images - Stage 2
Time frame: Within 5 minutes before injection
Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1
Time frame: Within 5 minutes after injection
Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2
Time frame: Within 5 minutes after injection
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1
Time frame: Within 5 minutes after injection
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2
Time frame: Within 5 minutes after injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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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.
Bayer Study Director study director
Bayer
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gadopentetate dimeglumine (Magnevist, BAY86-6661) in people with Magnetic Resonance Imaging, run by Bayer at 13 sites in 2 countries.
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 3 inclusion and 3 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 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set) (time frame: Within 5 minutes after injection). The study lists 9 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 18 Nov 2015.