Undiagnosed masses
Conditions
Interventions
Percutaneous needle biopsy (one day, one time)
Sponsors
Okayama University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The patient has a target lesion that cannot be diagnosed by noninvasive examinations and needs percutaneous needle biopsy for pathological diagnosis. 2) The size of the target lesion is larger than 20mm. 3) A MRI coil developed for interventional procedures is applicable to the patient. 4) The target lesion is clearly visible in the images obtained by 1.2T open MRI. 5) It is assumed to be possible to obtain the specimen by a cutting needle. 6) The patient is expected to survive more than 28 days from the registration.
Exclusion criteria
Exclusion criteria: 1) The patient has contraindication of MRI. 2) The target lesion is too small to obtain the specimen. 3) Absence of the safe needle insertion pathway because of critical organs or vessel structures. 4) The patient has severe comorbidities such as severe heart failure (New York Heart Association [NYHA] Classification III or IV) or active infectious disease except viral hepatitis. 5) The patient has a fever higher than 38 celsius. 6) The patient with white blood-cell count <2,000/uL, hemoglobin <6.0g/dL, platelet count <50,000/uL, or PT-INR >1.5. 7) The patient is or may be pregnant. 8) The patient is regarded as inappropriate for being enrolled into the study by physicians because of the other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of MRI-guided needle biopsy with 1.2T open MRI: Evaluation of whether the biopsy needle is successfully inserted into the target lesion or not on MR images. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of MRI-guided needle biopsy with 1.2T open MRI: Evaluation of adverse events and troubles of the equipment. | — |
Countries
Japan
Contacts
Public ContactYusuke Matsui
Okayama University Hospital Department of Radiology
Outcome results
None listed