Evaluation of a Support Software in the Planning and Real-time Monitoring of the Insertion of Needles in Interventional Magnetic Resonance Imaging (MRI): Liver Biopsy Case (IFE)

University Hospital, Strasbourg, France

Status: Terminated

Conditions: Liver Biopsy

Treatments: Device: Planning@IFE and Standard@IFE Software; Device: MR Syngo (Numaris/4) software

Study type: Interventional

Funder types: Other

Identifiers

NCT02573545

5261

Details and patient eligibility

About

To demonstrate that the use of Standard @IFE and Planning@IFE features of the IFE software, compared to the current method, when planning and inserting the needle under MRI monitoring in the context of liver biopsies enable:

• a facilitation of the planning stages of the procedure (route path, marking of the entry point and alignment of the MRI cutaways on the planned path), resulting in a reduction in the duration of the planning stages,
• a facilitation of the real-time modification of MRI cutaways during the procedure, resulting in a reduction of the duration of the procedure

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is at least 18 years old
• Affiliated to a social security scheme
• Informed consent
• Patient with an indication of liver biopsy eligible for a biopsy under interventional MRI

Exclusion criteria

• Patient with a contraindication for MRI exam
• Patient with a contraindication for performing a biopsy
• Pregnancy
• Exclusion period
• Patient unable to receive and understand information about the study
• Patients under guardianship
• Patients under judicial protection

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Test group: with IFE

Experimental group

Description:

Patients treated with IFE software

Treatment:

Device: Planning@IFE and Standard@IFE Software

Test group: without IFE

Active Comparator group

Description:

Patients treated with Numaris 4 software

Treatment:

Device: MR Syngo (Numaris/4) software