CTIS2023-504699-73-00进行中（未招募）1 期
The evaluation of the effectiveness, safety and tolerability of treatment, using a specialized prostate-specific membrane antigen (PSMA) labeled with Lutetium177, in patients with recurrent and/or metastatic adenoid cystic carcinoma originating from the salivary glands - an open, non-commercial clinical trial - LuRM_ACC/2023
arodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy0 个研究点目标入组 32 人开始时间: 2023年5月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Giving written informed consent to participate in the study., Patients with unresectable, locoregionally advanced or metastatic, histopathologically proven Adenoid Cystic Carcinoma of salivary glands., Age over 18 years., WHO Performance Status 0 to 2., 68Ga-PSMA PET/CT proven expression of PSMA; a positive result is considered as a qualitative assessment equal or greater than accumulation in functional liver., Progression of disease confirmed by imaging scans according to RECIST 1.1 criteria., Adequate function of: Bone marrow - neutrophils >1500x109/L; thrombocytes >150 000x109/L, hemoglobin >9 g/dl; Liver - bilirubin <2xULN (upper limit of normal range); aminotransferase <3xULN (patients with liver metastases <5xULN); Kidneys - eGFR >50 ml/min; Albumins >2,5 mg/ml, In women with procreative ability: confirmed negative pregnancy test result and consent to the implementation of double barrier contraception method., In men with procreative ability: consent to the implementation of double barrier contraception method.
排除标准
- •Pregnancy or breastfeeding., Lack of effective contraception in childbearing age., Patients with brain, cerebral meninges or heart metastases., Severe or significant concomitant disease in the investigator's assessment., Urinary tract obstruction or/and hydronephrosis., Concurrent anticancer treatment., Myelosuppressive or nuclear treatment within 4 weeks before enrollment to the study.
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