Gadobutrol Magnevist-controlled Body Study

NCT01050829 | Completed Phase 3

• 1 other identifier: 13297
• Study Type: interventional
• Target: 370
• Locations: 3 countries
• Sites: 15

Brief Summary

The purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the body/extremities regions. The results of the MRI with gadobutrol injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with Magnevist.

Conditions

Magnetic Resonance Imaging

Keywords

Magnetic resonance imaging; Tumor; Contrast media; Gadobutrol

Outcome Measures

Primary Outcomes (1)

• The total score of the following 3 visualization parameters is used for primary variable: Degree of contrast enhancement; Border delineation; Internal morphology.

  At Day 0

Secondary Outcomes (3)

• Sensitivity and specificity for the detection of malignant lesions

  At Day 0

• Exact match of the MR diagnosis with the final clinical diagnosis based on medical records up until 3 months after the scan

  At Day 0

• Confidence in diagnosis

  At Day 0

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Gadobutrol (Gadovist, BAY86-4875)

Arm 2

ACTIVE COMPARATOR

Drug: Gadopentetate Dimeglumine (Magnevist, BAY86-4882)

Interventions

Gadobutrol (Gadovist, BAY86-4875) DRUG

Single administration at a dose of 0.1 mmol/kg

Arm 1

Gadopentetate Dimeglumine (Magnevist, BAY86-4882) DRUG

Single administration at a dose of 0.1 mmol/kg

Arm 2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is at least 20 years of age
• Is referred for a contrast-enhanced MRI of the body/extremities based on current clinical symptoms or results of a previous imaging procedure
• Is willing to undergo the routine contrast-enhanced MRI examinations
• Is willing and able to complete all study procedures specified in the protocol
• Subject is male, or is female not of childbearing potential, or is female of childbearing potential who is using any medically accepted means of contraception and has a negative urine pregnancy test prior to the administration of gadobutrol or Magnevist

You may not qualify if:

• Is a female subject who is pregnant or nursing
• Has received any investigational product or has participated in any other clinical trial within 2 weeks prior to enrolling in this study
• Has been previously enrolled in this study or any other study using gadobutrol
• Has any contraindication to the MRI examinations or the use of Gd-containing contrast agents
• Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
• Has received any contrast agent within 24 hours prior to the study MRI
• Has a glomerular filtration rate value \<30 mL/min/1.73m2 derived from a serum creatinine result within 4 weeks prior to study enrollment
• Is considered clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure)
• Has severe cardiovascular disease (eg, acute myocardial infarction (\<14 days), unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (\<48 hours)
• Patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period
• Has any contraindication to Magnevist according to the package insert

Sponsors & Collaborators

• Bayer: lead

Study Sites (15)

Unknown Facility

Nanjing, Jiangsu, 210009, China

Location

Unknown Facility

Suzhou, Jiangsu, 215006, China

Location

Unknown Facility

Xi’an, Shanxi, 710032, China

Location

Unknown Facility

Beijing, 100853, China

Location

Unknown Facility

Shanghai, 200032, China

Location

Unknown Facility

Shanghai, 200233, China

Location

Unknown Facility

Kamogawa, Chiba, 296-0041, Japan

Location

Unknown Facility

Matsuyama, Ehime, 791-0280, Japan

Location

Unknown Facility

Chikushino-shi, Fukuoka, 818-8516, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, 812-0033, Japan

Location

Unknown Facility

Kobe, Hyōgo, 650-0047, Japan

Location

Unknown Facility

Sunto, Shizuoka, 411-8777, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Unknown Facility

Seoul, 150-713, South Korea

Location

Unknown Facility

Seoul, 158-710, South Korea

Location

MeSH Terms

Conditions

Neoplasms

Interventions

gadobutrol; Gadolinium DTPA

Intervention Hierarchy (Ancestors)

Pentetic Acid; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Coordination Complexes

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 15, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

CN (6); JP (7); KR (2)