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

NCT01613417 | Completed Phase 4 Results

• 1 other identifier: PH-107
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Disease

Keywords

Have confirmed or are highly suspected of brain disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Lesion Border Delineation

  Comparison of image sets obtained within 2 to 14 days

• Lesion Internal Morphology

  Comparison of image sets obtained within 2 to 14 days

• Extent of Disease

  Comparison of image sets obtained within 2 to 14 days

• Lesion Contrast Enhancement

  Comparison of image sets obtained within 2 to 14 days

• Lesion to Background Ratio on Post T1-weighed Spin Echo Images

  5-10 minutes Postdose

Study Arms (2)

MRI with Gadoteridol

ACTIVE COMPARATOR

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

Drug: gadoteridol; Drug: gadobutrol

MRI with Gadobutrol

ACTIVE COMPARATOR

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

Drug: gadoteridol; Drug: gadobutrol

Interventions

gadoteridol DRUG

ProHance 0.1 mmol/kg

Also known as: ProHance

MRI with Gadobutrol; MRI with Gadoteridol

gadobutrol DRUG

Gadovist/Gadavist 0.1 mmol/kg

Also known as: Gadovist, Gadavist

MRI with Gadobutrol; MRI with Gadoteridol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (1)

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Related Publications (1)

• 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.

  PMID: 25300984 RESULT

MeSH Terms

Conditions

Brain Diseases

Interventions

gadoteridol; gadobutrol

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

Histologic confirmation of disease available for only 139/198 patients in the PP analysis. Of these, 128 patients had confirmed brain tumors and were available for the analyses of diagnostic performance (tumor detection and tumor characterization).

Results Point of Contact

• Title: Gianpaolo Pirovano, MD
• Organization: Executive Director, MRI

gianpaolo.pirovano@diag.bracco.com

609-514-2226

Study Officials

• Gianpaolo Pirovano, MD

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 7, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 1, 2015
• Results First Posted: June 3, 2015

Record last verified: 2015-06

Locations

US (1)