Unique ID issued by UMIN | UMIN000027127 |
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Receipt number | R000031084 |
Scientific Title | Investigation of availability of chemical shift MRI in a nodule shadow doubting pulmonary hamartoma or benign pulmonary tumor in chest CT |
Date of disclosure of the study information | 2017/04/25 |
Last modified on | 2022/11/09 11:15:18 |
Investigation of availability of chemical shift MRI in a nodule shadow doubting pulmonary hamartoma or benign pulmonary tumor in chest CT
LOGIK1701
Investigation of availability of chemical shift MRI in a nodule shadow doubting pulmonary hamartoma or benign pulmonary tumor in chest CT
LOGIK1701
Japan |
Pulmonary hamartoma
Pneumology | Chest surgery |
Others
NO
We prospectively collect the clinical information that chemical shift MRI was carried out in patients doubting pulmonary hamartoma or pulmonary benign tumor in chest CT in multicenter study and investigate availability of chemical shift MRI for preoperative diagnosis of pulmonary hamartoma by comparing with pathology findings after resection.
Others
Sensitivity and specificity of pulmonary hamartoma diagnosis by chemical shift MRI
Not applicable
Sensitivity and specificity of pulmonary hamartoma diagnosis by chemical shift MRI
Positive predictive value in the range of virtual prevalence, ratio of each operative method (enucleation, wedge resection, segmental resection, lobectomy and others), exploration of cut-off value of signal intensity index.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Device,equipment |
Chemical shift MRI is carried out in patients who pulmonary hamartoma or benign pulmonary tumor was suspected in chest CT and it is compared between the pathological results after tumor resection and the findings of chemical shift MRI
18 | years-old | <= |
Not applicable |
Male and Female
1) Patients providing the written informed consent. (legal representatives are included in the case of a minor subjects)
2) Patients in whom diagnosis of lung cancer is not confirmed and pulmonary hamartoma or benign pulmonary tumor was doubted in chest CT. In addition, patients with bronchial intervention for bronchial hamartoma are eligible.
3) Patients with 10 mm or more of nodal shadow in minor axis by CT.
4) Patients who agree to enforcement of chemical shift MRI within 3 months after enrollment.
5) Patients who agree to tumor resection within 6 months after chemical shift MRI enforcement.
6) Age >= 18 years of age at the time of enrollment.
7) PS 0 or 1.
1) Patients with apparent complication of suspicious primary or metastatic pulmonary tumors from imaging diagnosis and progress.
2) Patients with metastatic pulmonary tumor as primary lesion of 1:renal cell carcinoma, 2:hepatic cell carcinoma and 3:liposarcoma (because fat component is included in tumor) and without passed 5 year after occurrence of primary lesion.
3) Any other patients who are regarded as unsuitable for the study by the investigators.
4) Patients who can't medically and mentally have MRI examination
5) Patients who refuse the participation in the study
290
1st name | Masami |
Middle name | |
Last name | Sato |
Kagoshima University Hospital
Department of Thoracic Surgery
890-8520
8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
099-275-6490
m-sato@m2.kufm.kagoshima-u.ac.jp
1st name | Go |
Middle name | |
Last name | Kamimura |
Kagoshima University Hospital
Department of Operation
890-8520
8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
099-275-6490
k6474547@kadai.jp
Clinical Research Support Center Kyushu
Clinical Research Support Center Kyushu
Other
kagoshima University Hospital institutional review board
8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
099-275-6692
kyufsyomu@kuas.kagoshima-u.ac.jp
NO
2017 | Year | 04 | Month | 25 | Day |
Unpublished
109
No longer recruiting
2017 | Year | 01 | Month | 25 | Day |
2017 | Year | 03 | Month | 24 | Day |
2017 | Year | 04 | Month | 01 | Day |
2023 | Year | 03 | Month | 31 | Day |
2022 | Year | 12 | Month | 31 | Day |
2023 | Year | 05 | Month | 31 | Day |
2017 | Year | 04 | Month | 25 | Day |
2022 | Year | 11 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031084
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