Central Nervous System DiseasesPhase 3NCT00323310

Safety and Efficacy of MultiHance in Pediatric Patients

A Phase 3 study testing gadobenate dimeglumine in people with Central Nervous System Diseases, run by Bracco Diagnostics, Inc at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this study was to assess the safety and enhancing properties of the magnetic resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having central nervous system (CNS) disorders. Read more about this study

Who is it for?: Ages 2 to 17 years
Conditions the study is for: Central Nervous System Diseases
What is being tested?: gadobenate dimeglumine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 1 siteUnited States
Study dates: Apr 2006to Sep 2008
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 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Between 2 and 17 years of age
Informed consent from parents
Assent from patient where required
Known or highly suspected disease of the CNS and referred for either cranial or spinal MRI examination

Who cannot join

Contraindication to MRI
Undergoing MRI in an emergency situation
Known allergy to one or more of the ingredients in MultiHance
Sickle cell anemia moderate to severe renal impairment
Received another investigational compound within 30 days
Pregnancy
Lactating females
Likely to undergo an invasive procedure within 72 hours of receiving MultiHance

Trial locations and contacts

1 site in 1 country.

United States1 site

Bracco Diagnostics, Inc.
Princeton, New Jersey, 08540

Other trials in United States

About this study

Official title: A Phase III Multi-Center Open Label Study to Evaluate Safety and Efficacy of MultiHance at the Dose of 0.10 mmol/kg in Magnetic Resonance Imaging of the Central Nervous System in Pediatric Patients

Conditions: Central Nervous System Diseases
Being tested: gadobenate dimeglumine
Keywords: disease of the central nervous system (brain or spine)
Medical subject headings: Central Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

gadobenate dimeglumineDrug
Also called MultiHance
A dose of 0.10 mmol/kg (i.e., 0.2 mL/kg) of 0.5 molar MultiHance was injected intravenously at a rate of 2 mL/sec as a single dose.

Study groups in NCT00323310
Study group	Role	What they receive
Gadobenate Dimeglumine	Experimental	Not described Receives: Drug: gadobenate dimeglumine

What is being measured

The primary outcome is the main question the study is designed to answer.

Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1
5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose
Measured: pre-dose and immediately postdose
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2
5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose
Measured: pre-dose and immediately postdose
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3
5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose
Measured: pre-dose and immediately postdose
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1
5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose
Measured: pre-dose to immediately post dose
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2
5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose
Measured: pre-dose to immediately post dose
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3
5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose
Measured: pre-dose to immediately postdose
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1
5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose
Measured: pre-dose and immediately postdose
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2
5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose
Measured: pre-dose to immediately postdose
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3
5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose
Measured: pre-dose to immediately postdose
The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events
Measured: up to 72 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Sep 2008

First posted9 May 2006 (estimated)
Study startApr 2006
Primary completionSep 2008
Study completionSep 2008

Why it stopped: Adequate statistical power at 92 dosed pts to meet study objectives.

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 Central Nervous System DiseasesStudies of the same condition, open and under way.
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: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00323310
Sponsor's protocol ID: MH 110
Status last verified: Oct 2010
First submitted: 5 May 2006
Last updated: 22 Oct 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia

All Central Nervous System Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Multi-Center Open Label Study to Evaluate Safety and Efficacy of MultiHance at the Dose of 0.10 mmol/kg in Magnetic Resonance Imaging of the Central Nervous System in Pediatric Patients
ClinicalTrials.gov ID: NCT00323310
Acronym / sponsor ID: MH 110
Conditions: Central Nervous System Diseases
Keywords: disease of the central nervous system (brain or spine)
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Adequate statistical power at 92 dosed pts to meet study objectives.
Enrolment: 92 participants (actual)
Lead sponsor: Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 9 May 2006 (estimated)
Results: Posted 6 Oct 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Gadobenate Dimeglumine	Experimental	Drug: gadobenate dimeglumine

Who may qualify

Ages: 2 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Between 2 and 17 years of age
Informed consent from parents
Assent from patient where required
Known or highly suspected disease of the CNS and referred for either cranial or spinal MRI examination

Key exclusion criteria (8 listed)

Contraindication to MRI
Undergoing MRI in an emergency situation
Known allergy to one or more of the ingredients in MultiHance
Sickle cell anemia moderate to severe renal impairment
Received another investigational compound within 30 days

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
gadobenate dimeglumineAlso: MultiHanceA dose of 0.10 mmol/kg (i.e., 0.2 mL/kg) of 0.5 molar MultiHance was injected intravenously at a rate of 2 mL/sec as a single dose.	Drug	Gadobenate Dimeglumine

Primary outcome

Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1
Time frame: pre-dose and immediately postdose
5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2
Time frame: pre-dose and immediately postdose
5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3
Time frame: pre-dose and immediately postdose
5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1
Time frame: pre-dose to immediately post dose
5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2
Time frame: pre-dose to immediately post dose
5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3
Time frame: pre-dose to immediately postdose
5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1
Time frame: pre-dose and immediately postdose
5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2
Time frame: pre-dose to immediately postdose
5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3
Time frame: pre-dose to immediately postdose
5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose
The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events
Time frame: up to 72 hours post dose

Results and safety

Results posted to the registry on 6 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gadobenate Dimeglumine	92	89

Primary outcome: Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1

Time frame: pre-dose and immediately postdose. Mean (Standard Deviation). Unit: Units on a Scale (0 to 4)

Measure	Gadobenate Dimeglumine n = 92
Predose	1.7 (1.16)
Pre+Postdose	3.0 (1.20)

Gadobenate Dimeglumine: Mean Difference (Final Values): 1.3 (95% CI 1.1 to 1.5), p <0.0001, t-test, 2 sided

Population analysed: Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.

Primary outcome: Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2

Time frame: pre-dose and immediately postdose. Mean (Standard Deviation). Unit: Units on a Scale (0 to 4)

Measure	Gadobenate Dimeglumine n = 92
Predose	1.9 (1.15)
Pre+Postdose	3.1 (1.11)

Gadobenate Dimeglumine: Mean Difference (Final Values): 1.2 (95% CI 0.9 to 1.4), p <0.0001, t-test, 2 sided

Population analysed: Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.

Primary outcome: Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3

Time frame: pre-dose and immediately postdose. Mean (Standard Deviation). Unit: Units on a Scale (0 to 4)

Measure	Gadobenate Dimeglumine n = 92
Predose	1.7 (1.19)
Pre+Postdose	2.4 (1.12)

Gadobenate Dimeglumine: Mean Difference (Final Values): 0.7 (95% CI 0.4 to 0.9), p <0.0001, t-test, 2 sided

Population analysed: Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.

Primary outcome: Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1

Time frame: pre-dose to immediately post dose. Mean (Standard Deviation). Unit: Units on a Scale (0 to 4)

Measure	Gadobenate Dimeglumine n = 92
Predose	1.9 (1.18)
Pre+Postdose	3.2 (1.19)

Gadobenate Dimeglumine: Mean Difference (Final Values): 1.3 (95% CI 1.1 to 1.6), p <0.001, t-test, 2 sided

Population analysed: Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gadobenate Dimeglumine	0 of 92 (0%)	8 of 92 (8.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Central Nervous System Diseases

RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia

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.

Gianpaolo Pirovano, M.D. study director

Bracco Diagnostics, Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gadobenate dimeglumine in people with Central Nervous System Diseases, run by Bracco Diagnostics, Inc at 1 site 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 22 Oct 2010. 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 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.

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 6 Oct 2010). 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?

Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1 (time frame: pre-dose and immediately postdose). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00323310.

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 22 Oct 2010.