1.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).
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.A Questionnaire Survey on Extracorporeal Membrane Oxygenation Targeting Under-Forty Cardiovascular Surgeons No.8
Tatsuki FUJIWARA ; Akinori HIRANO ; Chiharu TANAKA ; Hiroo KINAMI ; Hiroko KOGO ; Kenichiro TAKAHASHI ; Keita HAYASHI ; Toshiki FUJIYOSHI ; Keita MARUNO ; Toshiyuki YAMADA ; Kunihiko YOSHINO
Japanese Journal of Cardiovascular Surgery 2018;47(6):6-U1-6-U7
Basic procedures that cardiovascular surgeons routinely perform are rarely discussed, despite the great variability among facilities. We conducted a questionnaire survey on Extracorporeal Membrane Oxygenation (ECMO) targeting under-forty cardiovascular surgeons and obtained responses from 53 surgeons. We report the questionnaire results.
7.Evaluation of Trunk Stability in the Sitting Position Using a New Device
Kimio Saito ; Yoichi Shimada ; Naohisa Miyakoshi ; Toshiki Matsunaga ; Takehiro Iwami ; Michio Hongo ; Yuji Kasukawa ; Hidetomo Saito ; Norimitsu Masutani ; Yasuhiro Takahashi ; Satoaki Chida ; Kazutoshi Hatakeyama ; Motoyuki Watanabe ; Junki Ishikawa ; Yusuke Takahashi ; Masamichi Suzuki ; Shu Murata
The Japanese Journal of Rehabilitation Medicine 2017;54(1):31-35
8.Successful Surgical Intervention for Infected Mitral Endocarditis in a Patient Complicated with Multiple Cerebral Infarction and Hemorrhage
Junki Yokota ; Hiroyuki Nishi ; Naosumi Sekiya ; Mitsutomo Yamada ; Toshiki Takahashi
Japanese Journal of Cardiovascular Surgery 2016;45(1):37-40
The optimal timing of cardiac surgery for infective endocarditis in patients with severe brain complication remains unclear. We present here the successful surgical treatment of a case of infected mitral endocarditis with intractable heart failure, disseminated intravascular coagulation (DIC), and cerebral infarction with hemorrhage. A 37 year-old woman who received chemotherapy for breast cancer developed mitral infective endocarditis perhaps caused by infection of the implanted central venous access device and was referred to our hospital for an emergency operation. On admission, she had a mild fever and showed motor aphasia and right-sided hemiplegia. Brain CT scan findings revealed a cerebral infarction in the area of the left middle cerebral artery and a cerebral hemorrhage in the right occipital lobe. Echocardiography showed severe mitral regurgitation with huge mobile vegetation. Chest X-ray revealed severe pulmonary congestion and laboratory data showed DIC. After the mitral valve replacement with a bioprosthetic valve following complete excision of infected tissue, she was extubated on the first postoperative day with dramatic improvement of infectious signs and heart failure. Postoperative brain CT showed a new small brain hemorrhage, but no aggravation of the preoperative cerebral lesion. After she underwent surgical drainage for brain abscess on the 15th postoperative day, her postoperative course was uneventful. Even though this report is limited to a single case, only aggressive and prompt surgical intervention could relieve the intractable conditions in such a patient with extremely high risk.
9.A Case of Redo Aortic Valve Replacement for Bioprosthetic Aortic Valve Endocarditis Combined with Pyogenic Vertebral Osteomyelitis, Causing Prosthetic Valve Deterioration despite Effective Antibiotic Therapy
Hitoshi Suhara ; Toshiki Takahashi ; Takashi Kido ; Masaya Kainuma
Japanese Journal of Cardiovascular Surgery 2015;44(2):87-91
Infective endocarditis in association with pyogenic vertebral osteomyelitis is rarely observed. We report an 80-year-old man with infective endocarditis and pyogenic vertebral osteomyelitis requiring reoperation due to aortic prosthetic valve dysfunction. He suffered from back pain as the initial symptom, and he was admitted to our hospital. On magnetic resonance imaging, vertebral osteomyelitis was revealed, and antibiotics were started. On blood sampling α-streptococcus was identified and infective endocarditis was diagnosed. He responded to the antibiotic treatment. Despite the improvement in his general condition and the inflammatory parameters of blood samples, the aortic prosthetic valve dysfunction progressed. On echocardiography, aortic regurgitation worsened to 4/4, and the ejection fraction decreased from 72 to 46%. As heart failure was apparent, we performed a redo aortic valve replacement. Tears were found in the leaflets of the removed prosthetic valve (Hancock II). The 21-mm Carpentier-Edwards PERIMOUNT valve (CEP Magna Ease TFX) was replaced. His post-operative course was uneventful, and intravenous administration of ampicillin was continued. Oral rifampicin was also continued. On the 69th post-operative day, he was discharged and was ambulatory. Although we have no evidence that the tissue valve deterioration had resulted from bacterial damage, we were able to confirm that the structural valve deterioration involved bacterial contact in this case. Patients with infective endocarditis and pyogenic vertebral osteomyelitis should be treated cautiously regardless of whether or not the inflammation is controlled.
10.Aorto-left Ventricular Fistula with the Unruptured Aneurysm of the Sinus of Valsalva due to the Infective Endocarditis : A Rare Case Report
Takuya Higuchi ; Toshiki Takahashi ; Hitoshi Suhara ; Daisuke Yoshioka
Japanese Journal of Cardiovascular Surgery 2013;42(1):30-33
We reported a rare case of aorto-left ventricular fistula with the unruptured aneurysm of the Valsalva sinus due to the infective endocarditis. Preoperatively trans-echocardiographic examination revealed the ruptured left sinus of Valsalva aneurysm protruded toward the left ventricule. Aorto-left ventricular fistula contiguous to the unruptured aneurysm of the right valsalva sinus, however, was detected at operation. Granulation tissue resembling healed infective vegetation was detected in the margin among the orifices of this fistula and Valsalva aneurysm. Pathological examination showed excessive accumulation of white blood cells, which suggested infective endocarditis.


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