Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Bayer

Status and phase: Completed; Phase 2

Conditions: Spinal Cord Diseases; Brain Diseases

Treatments: Drug: Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875); Drug: OptiMARK~0.1 mmol/kg BW; Drug: Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875); Drug: Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00862459

308200 (Other Identifier)

91400

Details and patient eligibility

About

The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI with Gadavist Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with OptiMARK.

Full description

Safety issues are addressed in the Adverse Events section

Enrollment: 237 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with either known or highly suspected focal areas of disruption of the blood brain barrier (BBB) (eg, primary and secondary tumors, focal inflammatory or demyelinating disorders) and/or abnormal vascularity in the CNS, who are scheduled to undergo a routine contrast-enhanced MRI of the CNS.
• Patients with untreated brain tumors should constitute a minimum of 50% of the study population and patients with treated brain tumors will be limited to a maximum of 20% of the study population

Exclusion criteria

• Is a female patient who is pregnant or nursing.
• Is a female of childbearing potential and did not have a negative urine pregnancy test the same day as the administration of gadobutrol or comparator treatment.
• Has received any investigational product within 30 days 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.
• 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 gadobutrol contrast administration, or is scheduled to receive any contrast agent within 72 hours after the gadobutrol study.
• Is considered to be clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure).
• Has been treated with high dose (>55 cobalt Gy equivalent) photon radiation or global radiotherapy for CNS lesions at any time before entering the study.
• Is scheduled to receive chemotherapy or radiotherapy during the study period.
• Is expected or scheduled to have a change in any treatment or procedure between the comparator and gadobutrol MRIs that may alter their interpretation.
• Is scheduled or is likely to require a biopsy or surgery within the 72 hours after the gadobutrol MRI procedure, or is scheduled for or has undergone such interventions between the comparator and gadobutrol studies.
• Has severe cardiovascular disease.
• Has any contraindication to OptiMARK according to the package insert.
• Has more than 30 brain lesions detected by any prior imaging examination.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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237 participants in 3 patient groups

Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)

Experimental group

Description:

Participant received one dose of 0.03 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg body weight (BW) of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

Treatment:

Drug: Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)

Drug: OptiMARK~0.1 mmol/kg BW

Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)

Experimental group

Description:

Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

Treatment:

Drug: Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)

Drug: OptiMARK~0.1 mmol/kg BW

Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)

Experimental group

Description:

Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

Treatment:

Drug: Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)

Drug: OptiMARK~0.1 mmol/kg BW