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

Brain Disease Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613417
• Other study ID #: PH-107
• Status: Completed
• Phase: Phase 4
• First received: June 4, 2012
• Last updated: June 4, 2015
• Start date: August 2012
• Est. completion date: April 2014

Study information

• Verified date: June 2015
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCzech Republic: Ethics CommitteePoland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Disease
• Brain Diseases

Intervention

Drug:
• gadoteridol
ProHance 0.1 mmol/kg
• gadobutrol
Gadovist/Gadavist 0.1 mmol/kg

Locations

Country	Name	City	State
United States	Holy Name Medical Center	Teaneck	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States, 

References & Publications (1)

Maravilla KR, Smith MP, Vymazal J, Goyal M, Herman M, Baima JJ, Babbel R, Vaneckova M, Žižka 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 macro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Comparison of image sets obtained within 2 to 14 days	No
Secondary	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.	Comparison of image sets obtained within 2 to 14 days	No
Secondary	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.	Comparison of image sets obtained within 2 to 14 days	No
Secondary	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.	Comparison of image sets obtained within 2 to 14 days	No
Secondary	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.	Comparison of image sets obtained within 2 to 14 days	No
Secondary	Lesion to Background Ratio on Post T1-weighed Spin Echo Images	Mean of difference in signal intensity postdose (ProHance - Gadovist/Gadavist)	5-10 minutes Postdose	No
Secondary	Percentage Signal Intensity Enhancement on Postdose Images	Mean difference in percentage signal intensity enhancement on postdose T1-weighted SE/FSE images (ProHance - Gadovist/Gadavist)	5-10 minutes Postdose	No
Secondary	Lesion Detection	Lesion detection rate by contrast agent and reader	5-10 minutes Postdose	No
Secondary	Accuracy for Tumor Characterization	Blinded reader assessment of accuracy of tumor characterization (benign/malignant) - patient level assessment	5-10 minutes Postdose	No