1.A Surgical Case Report of the Fungal Prosthetic Valve Endocarditis after Aortic Valve Replacement and Annular Enlargement
Osanori Sogabe ; Satoshi Nishizawa ; Masami Yamane ; Hajime Maeta
Japanese Journal of Cardiovascular Surgery 2005;34(4):287-290
We report a 64-year-old woman with fungal prosthetic valve endocarditis. She underwent the aortic valve replacement (SJM 19 A®) with annular enlargement using autologous pericardium. She had a persistent fever and congestive heart failure 8 months after surgery. Echocardiogram demonstrated vegetations of the aortic prosthetic valve, perivalvular leakage and third degree mitral valve regurgitation. Double valve replacement was performed concomitant with aortic annular enlargement using a xenograft. The aortic valve prosthesis was found to be detached from the aortic annulus on the side of the left coronary sinus and also from the implanted autologous pericardium. There were vegetations on the aortic prosthesis and the autologous pericardium. Histopathological findings led to the diagnosis of fungal endocarditis of the aortic prosthetic valve and antifungal therapy was started on the second postoperative day. She is in good condition 5 years later without any relapse of inflammation and has been receiving antifungal treatment. The surgical method of aortoatrioplasty with double valve replacement was effective for fungal prosthetic valve endocarditis after aortic valve replacement with annular enlargement.
2.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
3.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
4.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
5.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
6.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).