Crossover Comparison of MultiHance and Dotarem (BENEFIT)

November 14, 2016 updated by: Bracco Diagnostics, Inc

Phase IV, Double Blind, Multi-Center, Randomized, Two-Arm Crossover Study to Compare 0.1 mmol/kg of MultiHance With 0.1 mmol/kg of Dotarem and 0.05 mmol/kg of MultiHance With 0.1 mmol/kg of Dotarem in MRI of the Brain

This study aims at a comparison between MultiHance at a dose of 0.1 mmol/kg and 0.05 mmol/kg and Dotarem at a dose of 0.1 mmol/kg in brain tumor patients to show superiority of MultiHance.

Study Overview

Detailed Description

This crossover study aims at a comparison between 0.1 mmol/kg MultiHance and 0.1 mmol/kg Dotarem, between 0.05 MultiHance and 0.1 mmol/kg Dotarem in terms of diagnostic preference at CE-MRI in brain tumor patients to show superiority of MultiHance.

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Samaritan Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Are at least 18 years of age or older
  • Are able to give written informed consent and are willing to comply with the protocol requirements
  • Are scheduled to undergo MRI
  • Are willing to undergo two MRI procedures within 14 days
  • Have confirmed or are highly suspected to have brain tumor(s) (primary or secondary), as determined by:
  • Clinical/neurological symptomatology;
  • Diagnostic testing, such as CT or previous MRI examinations; or
  • Have had recent brain surgery and are to be evaluated for recurrence

Exclusion Criteria:

  • Are pregnant or lactating females. Exclude the possibility of pregnancy:
  • By testing on site at the institution within 24 hours prior to the start of each investigational product administration; or
  • By history (i.e., tubal ligation or hysterectomy); or
  • Post menopausal with a minimum of 1 year without menses
  • Have any known allergy to one or more of the ingredients in the investigational products, or have a history of hypersensitivity to any metals
  • Have congestive heart failure (class IV according to the classification of the New York Heart Association)
  • Have suffered a stroke within a year
  • Have received or are scheduled to receive any other contrast medium in the 24 hours preceding through the 24 hours following Exam 1, and in the 24 hours preceding through the 24 hours following Exam 2
  • Have received or are scheduled to receive an investigational compound and/or medical device within 30 days before admission into the present study, through the 24 hours post-administration of the second investigational product
  • Have moderate-to-severe renal impairment, defined as Glomerular Filtration Rate (GFR)/estimated GFR < 45 mL/min
  • Have been previously entered into this study
  • Have received or are scheduled for one of the following:
  • Surgical or chemotherapeutic treatment within three weeks prior to the first examination or between the two examinations
  • Initiation of steroid therapy between the two examinations
  • Radiosurgery between the two examinations
  • Have any contraindications to MRI such as a pace-maker, magnetic material (i.e., surgical clips) or any other conditions that would preclude proximity to a strong magnetic field
  • Are suffering from severe claustrophobia
  • Have any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MultiHance 0.1 then Dotarem 0.1 mmol/kg
MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg
MultiHance administered at 0.1 mmol/kg
Dotarem administered at 0.1 mmol/kg
Other Names:
  • Dotarem 0.1 mmol/kg
EXPERIMENTAL: MultiHance 0.05 then Dotarem 0.1 mmol/kg
MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg
Dotarem administered at 0.1 mmol/kg
Other Names:
  • Dotarem 0.1 mmol/kg
MultiHance administered at 0.05 mmol/kg
ACTIVE_COMPARATOR: Dotarem 0.1 then MultiHance 0.1 mmol/kg
Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg
MultiHance administered at 0.1 mmol/kg
Dotarem administered at 0.1 mmol/kg
Other Names:
  • Dotarem 0.1 mmol/kg
ACTIVE_COMPARATOR: Dotarem 0.1 then MultiHance 0.05 mmol/kg
Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg
Dotarem administered at 0.1 mmol/kg
Other Names:
  • Dotarem 0.1 mmol/kg
MultiHance administered at 0.05 mmol/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Diagnostic Preference Between the Two Exams
Time Frame: Comparison of image sets obtained within 2 to 14 days
Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.
Comparison of image sets obtained within 2 to 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion Border Delineation
Time Frame: Comparison of image sets obtained within 2 to 14 days
Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.
Comparison of image sets obtained within 2 to 14 days
Lesion Internal Morphology
Time Frame: Comparison of image sets obtained within 2 to 14 days
Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.
Comparison of image sets obtained within 2 to 14 days
Extent of Disease
Time Frame: Comparison of image sets obtained within 2 to 14 days
Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.
Comparison of image sets obtained within 2 to 14 days
Lesion Contrast Enhancement
Time Frame: Comparison of image sets obtained within 2 to 14 days
Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.
Comparison of image sets obtained within 2 to 14 days
Lesion to Background Ratio on Post T1-weighed Spin Echo Images
Time Frame: 5-10 minutes Postdose
The Unit of Measure is lesion-to-background ratio based on lesions assessed. For each lesion, Lesion-to-background ratio (LBR) = SI of lesion/SI of brain. Firstly, LBR of each lesion was assessed for each contrast agent postdose image separately, then the difference in LBR between MultiHance and Dotarem was calculated. The number presented in the result table below is "the mean difference in LBR postdose (MultiHance - Dotarem)"
5-10 minutes Postdose
Lesion-brain Contrast-to-noise Ratio
Time Frame: 5-10 minutes Postdose
The Unit of Measure is contrast-to-noise ratio based on lesions assessed. For each lesion, Lesion-brain Contrast-to-noise Ratio (CNR) = [(SI of lesion - SI of brain)/SD for SI of noise] on Postdose Images of each lesion was calculated for each contrast agent image separately, then the difference in CNR between MultiHance and Dotarem was calculated. The number presented in the result table below is "the mean difference in CNR (MultiHance - Dotarem)"
5-10 minutes Postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

February 20, 2014

First Submitted That Met QC Criteria

February 24, 2014

First Posted (ESTIMATE)

February 25, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2017

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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