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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)


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Brain Disease

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Non-inferiority of each exam based on pre-dose and post dose images

Outcome Description:

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).

Outcome Time Frame:

Up to 14 days

Safety Issue:

No

Principal Investigator

Gianpaolo Pirovano, MD

Investigator Role:

Study Director

Investigator Affiliation:

Bracco Diagnostics, Inc

Authority:

United States: Institutional Review Board

Study ID:

PH-107

NCT ID:

NCT01613417

Start Date:

August 2012

Completion Date:

December 2013

Related Keywords:

  • Brain Disease
  • Have confirmed or are highly suspected of brain disease
  • Brain Diseases

Name

Location

Holy Name Medical CenterTeaneck, New Jersey  07666