Feasibility study of MRI-guided biopsy with 1.2T open MRI

JRCT ID: jRCTs062180019

Registered date:31/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Undiagnosed mass
• Date of first enrollment: 28/06/2018
• Target sample size: 10
• Study type: Interventional
• Intervention(s): MRI-guided needle biopsy with 1.2T open MRI

Outcome(s)

• Primary Outcome: Feasibility of MRI-guided needle biopsy with 1.2T open MRI
• Secondary Outcome: Adverse events, Device failures, and Success of tissue specimen acquisition

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Target lesion that cannot be diagnosed by noninvasive examinations and needing percutaneous needle biopsy for pathological diagnosis.
2) Size of the target lesion larger than 20 mm.
3) Applicability of a body coil developed for MRI-guided procedures to the patient.
4) Target lesion clearly visible in the images obtained by 1.2T open MRI.
5) Target lesion from which acquisition of specimens by a cutting needle is assumed to be possible.
6) Expected survival time of the patient of more than 28 days from the registration.
7) Written informed consent provided by the patient.
8) Age of the patient 20 years old and older.

Exclude criteria

1) Presence of contraindication of MRI.
2) Target lesion that is too small for biopsy.
3) Absence of the safe needle insertion pathway because of the presence of critical organs or vessel structures.
4) Presence of severe comorbidities of patients such as severe heart failure (New York Heart Association Classification III or IV), or active infectious disease except viral hepatitis.
5) Presence of a fever higher than 38 degrees Celsius.
6) Laboratory findings of white blood-cell count <2,000/uL, hemoglobin <6.0 g/dL, platelet count <50,000/uL, or prothrombin time-international normalized ratio >1.5.
7) Pregnant status.
8) Inappropriateness of the candidate for the study judged by the investigators because of other reasons.

Related Information

• Primary Sponsor: Matsui Yusuke
• Source(s) of Monetary Support: Japan Society for the Promotion of Science,Guerbet Japan,Siemens Healthineers,Daiichi-Sankyo,Toray Medical,Nihon Medi-Physics,FUJIFILM RI Pharma,FUJIFILM Medical,Fuji Pharma,Eisai,Nippon Kayaku
• Secondary ID(s): UMIN000030365