Unique ID issued by UMIN | UMIN000030365 |
---|---|
Receipt number | R000029608 |
Scientific Title | MRI-guided percutaneous needle biopsy with 1.2T open MRI: a single institution, single arm, prospective, open feasibility study |
Date of disclosure of the study information | 2018/02/01 |
Last modified on | 2019/12/14 12:31:28 |
MRI-guided percutaneous needle biopsy with 1.2T open MRI: a single institution, single arm, prospective, open feasibility study
SCIRO-1701
MRI-guided percutaneous needle biopsy with 1.2T open MRI: a single institution, single arm, prospective, open feasibility study
SCIRO-1701
Japan |
Undiagnosed masses
Radiology |
Malignancy
NO
Feasibility of MRI-guided needle biopsy with 1.2T open MRI
Safety
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.
Safety of MRI-guided needle biopsy with 1.2T open MRI: Evaluation of adverse events and troubles of the equipment.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Device,equipment | Maneuver |
Percutaneous needle biopsy (one day, one time)
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
10
1st name | |
Middle name | |
Last name | Yusuke Matsui |
Okayama University Hospital
Department of Radiology
2-5-1 Sikata-cho, Kita-ku, Okayama, Japan
086-235-7313
y-matsui@okayama-u.ac.jp
1st name | |
Middle name | |
Last name | Yusuke Matsui |
Okayama University Hospital
Department of Radiology
2-5-1 Sikata-cho, Kita-ku, Okayama, Japan
086-235-7313
y-matsui@okayama-u.ac.jp
Okayama University
Ministry of Education, Culture, Sports, Science and Technology-Japan
Japanese Governmental office
NO
2018 | Year | 02 | Month | 01 | Day |
Unpublished
Completed
2018 | Year | 01 | Month | 16 | Day |
2018 | Year | 01 | Month | 16 | Day |
2018 | Year | 04 | Month | 01 | Day |
2023 | Year | 03 | Month | 31 | Day |
2017 | Year | 12 | Month | 12 | Day |
2019 | Year | 12 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029608
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |