Crossover Comparison of MultiHance and Dotarem

NCT02070380 | Completed Phase 4 Results

• 1 other identifier: MH-148
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Disease

Keywords

confirmed brain disease; highly suspected brain disease

Outcome Measures

Primary Outcomes (1)

• Global Diagnostic Preference Between the Two Exams

  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 Outcomes (6)

• Lesion Border Delineation

  Comparison of image sets obtained within 2 to 14 days

• Lesion Internal Morphology

  Comparison of image sets obtained within 2 to 14 days

• Extent of Disease

  Comparison of image sets obtained within 2 to 14 days

• Lesion Contrast Enhancement

  Comparison of image sets obtained within 2 to 14 days

• Lesion to Background Ratio on Post T1-weighed Spin Echo Images

  5-10 minutes Postdose

Study Arms (4)

MultiHance 0.1 then Dotarem 0.1 mmol/kg

EXPERIMENTAL

MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg

Drug: MultiHance 0.1 mmol/kg; Drug: Dotarem

MultiHance 0.05 then Dotarem 0.1 mmol/kg

EXPERIMENTAL

MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg

Drug: Dotarem; Drug: MultiHance 0.05 mmol/kg

Dotarem 0.1 then MultiHance 0.1 mmol/kg

ACTIVE COMPARATOR

Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg

Drug: MultiHance 0.1 mmol/kg; Drug: Dotarem

Dotarem 0.1 then MultiHance 0.05 mmol/kg

ACTIVE COMPARATOR

Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg

Drug: Dotarem; Drug: MultiHance 0.05 mmol/kg

Interventions

MultiHance 0.1 mmol/kg DRUG

MultiHance administered at 0.1 mmol/kg

Dotarem 0.1 then MultiHance 0.1 mmol/kg; MultiHance 0.1 then Dotarem 0.1 mmol/kg

Dotarem DRUG

Dotarem administered at 0.1 mmol/kg

Also known as: Dotarem 0.1 mmol/kg

Dotarem 0.1 then MultiHance 0.05 mmol/kg; Dotarem 0.1 then MultiHance 0.1 mmol/kg; MultiHance 0.05 then Dotarem 0.1 mmol/kg; MultiHance 0.1 then Dotarem 0.1 mmol/kg

MultiHance 0.05 mmol/kg DRUG

MultiHance administered at 0.05 mmol/kg

Dotarem 0.1 then MultiHance 0.05 mmol/kg; MultiHance 0.05 then Dotarem 0.1 mmol/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (1)

Samaritan Health Services

Corvallis, Oregon, 97330, United States

Location

MeSH Terms

Conditions

Brain Diseases

Interventions

gadobenic acid; gadoterate meglumine

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Gianpaolo Pirovano, MD
• Organization: Bracco Diagnostics, Inc.

gianpaolo.pirovano@diag.bracco.com

609-514-2226

Study Officials

• Gianpaolo Pirovano, MD

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 25, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 10, 2017
• Results First Posted: January 10, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)