JPRN-jRCT2021220040招募中2 期
Multi-institutional phase II study of photodynamic therapy using ME2906 and PNL6405SCT for patients with malignant spinal cord tumor.
Endo Toshiki0 个研究点目标入组 20 人开始时间: 2023年1月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 15age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients scheduled for surgery for primary malignant spinal cord tumor removal (either total, subtotal, or partial removal, not biopsy only). Only single spinal cord tumor lesion, histopathologically suspected grade 3 or 4 in the WHO Classification of Tumors of the Central Nervous System (WHO 2016, Fourth Revised Edition) should be included. New onset or recurrent tumors are both included. In case of recurrent cases, the grade at the time of initial onset shall not be questioned.
- •2) In the case of new-onset cases, patients who have not undergone any curative treatment (previous biopsy surgery is not be questioned) are scheduled to receive standard radiation chemotherapy after the tumor resection. The recurrent cases indicate patients who subsequently relapse and require additional surgery despite some form of curative treatment.
- •3) MRI (contrast-enhanced T1-weighted image) is required to be taken within 4 weeks prior to enrollment. Patients are recruited when MRI shows the presence of a heterogeneously contrasted, borderline indistinct tumor in the spinal cord, suggesting a malignant spinal glioma of grade 3 or 4 in the WHO Classification of Tumors of the Central Nervous System (WHO 2016, Fourth Revised Edition).
- •4) Patients whose Brain MRI (contrast-enhanced T1-weighted image) taken within 4 weeks prior to enrollment shows no mass or dissemination requiring treatment in either the intracranial or pituitary regions.
- •5) MRI (contrast-enhanced T1-weighted images) taken within 4 weeks prior to enrollment showing no evidence of intrathecal dissemination or multiple spinal cord masses.
- •6) Patients who are at least 15 years of age at the time of consent. Gender is not specified.
- •7) Patients with a Karnofsky Performance Status (KPS) of 70 or higher at the time of consent, or a KPS of 50 or 60 due solely to neurological symptoms caused by the tumor.
- •8) Patients with adequate organ function and blood tests performed within 4 weeks prior to enrollment that meet the following criteria
- •WBC >=2000 /mm3, Hb >=8.0 g/dl, PLT >=80,000 /mm3, AST <=100 IU/l, ALT <=100 IU/l, Cre <=1.5 mg/dl
- •9) Informed consent taken from the patient. In case it is difficult to get the signature of patient due to neurological deficits, representative person may sign as long as patient is able to understand and give his or her approval.
排除标准
- •1) preexisting of sun photosensitivity or porphyria.
- •2) Patients with contraindication to MRI with contrast enhancement using gadolinium.
- •3) Patients who are participating in a clinical trial or clinical research that is different from this clinical trial (clinical trials such as for the purpose of genetic analysis or observational studies that do not involve therapeutic intervention for the target disease are acceptable).
- •4) Patients with serious cardiac, pulmonary, hematological, metabolic, hepatic, renal, or other complications. Their general condition is so poor that the investigators judge that they are unable to tolerate this clinical trial.
- •5) Patients with serious bleeding or in shock.
- •6) Patients with hemorrhagic diathesis.
- •7) IPatients with serious infections (patients with infections requiring systemic administration of antimicrobial agents, antivirals, etc. (excluding epidemic diseases and acute upper respiratory tract infection for which early recovery is expected))
- •8) Pregnant women or women who may be pregnant or nursing.
- •9) Patients who are unwilling to use an effective contraceptive method (e.g., condom, intrauterine device, oral contraceptive) to provide adequate contraception during the study period.
- •10) Patients with a malignant tumor other than primary malignant spinal cord tumor.
- •11) Any patients who are judged by the investigator or subinvestigator to be inappropriate as subjects for this clinical trial.
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