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Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain (TRUTH)

Primary Purpose

Brain Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
gadoteridol
gadobutrol
Sponsored by
Bracco Diagnostics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Disease focused on measuring Have confirmed or are highly suspected of brain disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Are scheduled to undergo MRI
  • Are willing to undergo two MRI procedures within 14 days
  • Have confirmed or are highly suspected of brain disease likely to enhance as determined by the following:
  • Clinical/neurological symptomatology;
  • Diagnostic testing, such as CT or previous MRI examinations; or
  • Have had previous 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; see Appendix A)
  • 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 a GFR/eGFR < 45 mL/min.
  • Have been previously entered into this study
  • Have received or are scheduled for one of the following:
  • Surgery 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

Sites / Locations

  • Holy Name Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MRI with Gadoteridol

MRI with Gadobutrol

Arm Description

MRI after 0.1 mmol/kg IV ProHance, then with 0.1 mmol/kg Gadovist/Gadavist. MRI performed after both agents with identical sequences.

MRI after 0.1 mmol/kg IV Gadovist/Gadavist, then with 0.1 mmol/kg ProHance. MRI performed after both agents with identical sequences.

Outcomes

Primary Outcome Measures

Global Diagnostic Preference Between the Two Exams
Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.

Secondary Outcome Measures

Lesion Border Delineation
Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Lesion Internal Morphology
Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Extent of Disease
Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Lesion Contrast Enhancement
Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Lesion to Background Ratio on Post T1-weighed Spin Echo Images
Mean of difference in signal intensity postdose (ProHance - Gadovist/Gadavist)
Percentage Signal Intensity Enhancement on Postdose Images
Mean difference in percentage signal intensity enhancement on postdose T1-weighted SE/FSE images (ProHance - Gadovist/Gadavist)
Lesion Detection
Lesion detection rate by contrast agent and reader
Accuracy for Tumor Characterization
Blinded reader assessment of accuracy of tumor characterization (benign/malignant) - patient level assessment

Full Information

First Posted
June 4, 2012
Last Updated
June 4, 2015
Sponsor
Bracco Diagnostics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01613417
Brief Title
Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain
Acronym
TRUTH
Official Title
Phase IV, Double-blind, Multi-center, Randomized, Crossover Study to Compare 0.1 mmol/kg of Prohance® With 0.1 mmol/kg of Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain (TRUTH)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bracco Diagnostics, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects with brain tumors to confirm the identical overall technical and diagnostic performance of the two MR contrast agents.
Detailed Description
Adult patients were given two MRI exams, one after injection of ProHance (0.1 mmol/kg) and one after injection of Gadovist/Gadavist (0.1 mmol/kg). The exams were performed with identical equipment and imaging parameters with the order of the two exams randomized and 2-14 days between the first and the second MRI exam. Image data was evaluated by 3 expert neuroradiologist blinded to the agent administered and patient clinical data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Disease
Keywords
Have confirmed or are highly suspected of brain disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI with Gadoteridol
Arm Type
Active Comparator
Arm Description
MRI after 0.1 mmol/kg IV ProHance, then with 0.1 mmol/kg Gadovist/Gadavist. MRI performed after both agents with identical sequences.
Arm Title
MRI with Gadobutrol
Arm Type
Active Comparator
Arm Description
MRI after 0.1 mmol/kg IV Gadovist/Gadavist, then with 0.1 mmol/kg ProHance. MRI performed after both agents with identical sequences.
Intervention Type
Drug
Intervention Name(s)
gadoteridol
Other Intervention Name(s)
ProHance
Intervention Description
ProHance 0.1 mmol/kg
Intervention Type
Drug
Intervention Name(s)
gadobutrol
Other Intervention Name(s)
Gadovist, Gadavist
Intervention Description
Gadovist/Gadavist 0.1 mmol/kg
Primary Outcome Measure Information:
Title
Global Diagnostic Preference Between the Two Exams
Description
Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Time Frame
Comparison of image sets obtained within 2 to 14 days
Secondary Outcome Measure Information:
Title
Lesion Border Delineation
Description
Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Time Frame
Comparison of image sets obtained within 2 to 14 days
Title
Lesion Internal Morphology
Description
Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Time Frame
Comparison of image sets obtained within 2 to 14 days
Title
Extent of Disease
Description
Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Time Frame
Comparison of image sets obtained within 2 to 14 days
Title
Lesion Contrast Enhancement
Description
Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Time Frame
Comparison of image sets obtained within 2 to 14 days
Title
Lesion to Background Ratio on Post T1-weighed Spin Echo Images
Description
Mean of difference in signal intensity postdose (ProHance - Gadovist/Gadavist)
Time Frame
5-10 minutes Postdose
Title
Percentage Signal Intensity Enhancement on Postdose Images
Description
Mean difference in percentage signal intensity enhancement on postdose T1-weighted SE/FSE images (ProHance - Gadovist/Gadavist)
Time Frame
5-10 minutes Postdose
Title
Lesion Detection
Description
Lesion detection rate by contrast agent and reader
Time Frame
5-10 minutes Postdose
Title
Accuracy for Tumor Characterization
Description
Blinded reader assessment of accuracy of tumor characterization (benign/malignant) - patient level assessment
Time Frame
5-10 minutes Postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are scheduled to undergo MRI Are willing to undergo two MRI procedures within 14 days Have confirmed or are highly suspected of brain disease likely to enhance as determined by the following: Clinical/neurological symptomatology; Diagnostic testing, such as CT or previous MRI examinations; or Have had previous 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; see Appendix A) 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 a GFR/eGFR < 45 mL/min. Have been previously entered into this study Have received or are scheduled for one of the following: Surgery 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianpaolo Pirovano, MD
Organizational Affiliation
Bracco Diagnostics, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25300984
Citation
Maravilla KR, Smith MP, Vymazal J, Goyal M, Herman M, Baima JJ, Babbel R, Vaneckova M, Zizka J, Colosimo C, Urbanczyk-Zawadzka M, Mechl M, Bag AK, Bastianello S, Bueltmann E, Hirai T, Frattini T, Kirchin MA, Pirovano G. Are there differences between macrocyclic gadolinium contrast agents for brain tumor imaging? Results of a multicenter intraindividual crossover comparison of gadobutrol with gadoteridol (the TRUTH study). AJNR Am J Neuroradiol. 2015 Jan;36(1):14-23. doi: 10.3174/ajnr.A4154. Epub 2014 Oct 9.
Results Reference
result

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Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain

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