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

NCT ID: NCT01613417

Last Updated: 2015-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 229 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-04-30

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.

Conditions

Brain Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

gadoteridol

Intervention Type: DRUG

ProHance 0.1 mmol/kg

gadobutrol

Intervention Type: DRUG

Gadovist/Gadavist 0.1 mmol/kg

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.

Group Type: ACTIVE_COMPARATOR

gadoteridol

Intervention Type: DRUG

ProHance 0.1 mmol/kg

gadobutrol

Intervention Type: DRUG

Gadovist/Gadavist 0.1 mmol/kg

Interventions

gadoteridol

ProHance 0.1 mmol/kg

Intervention Type: DRUG

gadobutrol

Gadovist/Gadavist 0.1 mmol/kg

Intervention Type: DRUG

Other Intervention Names

ProHance; Gadovist, Gadavist

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gianpaolo Pirovano, MD

Role: STUDY_DIRECTOR

Bracco Diagnostics, Inc

Locations

Holy Name Medical Center

Teaneck, New Jersey, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25300984 (View on PubMed)

Other Identifiers

PH-107

Identifier Type: -

Identifier Source: org_study_id