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Trial record 2 of 12 for:    gadoteridol

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

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ClinicalTrials.gov Identifier: NCT01613417
Recruitment Status : Completed
First Posted : June 7, 2012
Results First Posted : June 3, 2015
Last Update Posted : July 1, 2015
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

Tracking Information
First Submitted Date  ICMJE June 4, 2012
First Posted Date  ICMJE June 7, 2012
Results First Submitted Date  ICMJE April 28, 2015
Results First Posted Date  ICMJE June 3, 2015
Last Update Posted Date July 1, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2015)
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 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2012)
Non-inferiority of each exam based on pre-dose and post dose images [ Time Frame: Up to 14 days ]
To show non-inferiority of a 0.1 mmol/kg dose of PROHANCE as compared to 0.1 mmol/kg dose of GADOVIST/GADAVIST, in terms of the by-subject global diagnostic preference between exams (i.e., based on predose + postdose image sets).
Change History Complete list of historical versions of study NCT01613417 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2015)
  • Lesion Border Delineation [ Time Frame: Comparison of image sets obtained within 2 to 14 days ]
    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 [ Time Frame: Comparison of image sets obtained within 2 to 14 days ]
    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 [ Time Frame: Comparison of image sets obtained within 2 to 14 days ]
    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 [ Time Frame: Comparison of image sets obtained within 2 to 14 days ]
    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 [ Time Frame: 5-10 minutes Postdose ]
    Mean of difference in signal intensity postdose (ProHance - Gadovist/Gadavist)
  • Percentage Signal Intensity Enhancement on Postdose Images [ Time Frame: 5-10 minutes Postdose ]
    Mean difference in percentage signal intensity enhancement on postdose T1-weighted SE/FSE images (ProHance - Gadovist/Gadavist)
  • Lesion Detection [ Time Frame: 5-10 minutes Postdose ]
    Lesion detection rate by contrast agent and reader
  • Accuracy for Tumor Characterization [ Time Frame: 5-10 minutes Postdose ]
    Blinded reader assessment of accuracy of tumor characterization (benign/malignant) - patient level assessment
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Brain Disease
Intervention  ICMJE
  • Drug: gadoteridol
    ProHance 0.1 mmol/kg
    Other Name: ProHance
  • Drug: gadobutrol
    Gadovist/Gadavist 0.1 mmol/kg
    Other Name: Gadovist, Gadavist
Study Arms  ICMJE
  • Active Comparator: MRI with Gadoteridol
    MRI after 0.1 mmol/kg IV ProHance, then with 0.1 mmol/kg Gadovist/Gadavist. MRI performed after both agents with identical sequences.
    Interventions:
    • Drug: gadoteridol
    • Drug: gadobutrol
  • Active Comparator: MRI with Gadobutrol
    MRI after 0.1 mmol/kg IV Gadovist/Gadavist, then with 0.1 mmol/kg ProHance. MRI performed after both agents with identical sequences.
    Interventions:
    • Drug: gadoteridol
    • Drug: gadobutrol
Publications * Maravilla KR, Smith MP, Vymazal J, Goyal M, Herman M, Baima JJ, Babbel R, Vaneckova M, Žižka J, Colosimo C, Urbańczyk-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2014)
229
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2012)
206
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01613417
Other Study ID Numbers  ICMJE PH-107
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bracco Diagnostics, Inc
Study Sponsor  ICMJE Bracco Diagnostics, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gianpaolo Pirovano, MD Bracco Diagnostics, Inc
PRS Account Bracco Diagnostics, Inc
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP