ACTRN12623001157662招募中1 期
ptake, Safety and Tolerability of 68Ga-NTA-476 Imaging of Prostate Cancer Tumours
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- GenesisCare
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •1.Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.
- •2.Adult participants at least 18 years of age.
- •3.Participants with a documented history of histologically confirmed diagnosis of prostate cancer.
- •oParticipants must have PSA more than 0.1ng/mL.
- •oParticipants on chemotherapy may be approved on a case-by-case basis at the principal investigator's discretion if the last dose of chemotherapy is administered at least 3 weeks prior to receipt of 68Ga-NTA-476, and subsequent dose of chemotherapy are to resume following completion of End of Treatment Visit (EOTV), if it is determined not to put the patient at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.
- •oParticipants on other anti-cancer therapy, such as novel anti-androgen therapy, may be allowed on a case-by-case basis at the principal investigator's discretion, with an agreement of a washout period prior to 68Ga-NTA-476 dosing, if it is determined not to put the patient at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.
- •4.Eastern Cooperative Oncology Group (ECOG) performance status equal to or less than 2
- •5.Participants must have a life expectancy of more than 3 months in the opinion of the Investigator.
- •6.Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 14 days after the last injection of 68Ga-NTA-476. Participants must agree to not donate sperm during the study and for 14 days after the injection of 68Ga-NTA-476.
排除标准
- •7.Have any medical condition that would, in the Investigator’s judgment, prevent the participant’s full participation in the clinical study due to safety concerns or compliance with clinical study procedures, including but not limited to participants with severe claustrophobia.
- •8.Residual toxicity greater than Grade 1 from prior anti-cancer therapy (except alopecia). Participants with greater than Grade 1 toxicity from prior anti-cancer therapy may be approved on a case-by-case basis at the principal investigator's discretion, if it is determined not to put the patient at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.
- •9.History of uncontrolled allergic reactions and/or known or expected hypersensitivity to peptide therapeutics, including 68Ga-NTA-476 or any of its excipients.
- •10.Inadequate organ functions as reflected in laboratory parameters:
- •oCreatinine clearance (calculated using Cockcroft-Gault formula, or measured) less than 60 mL/min or serum creatinine greater than 1.5 x upper limit of normal (ULN)
- •oPlatelet count of less than 75 x 10^9/L
- •oAbsolute neutrophil count (ANC) less than 1.0 x 10^9/L
- •oHaemoglobin less than 9 g/dL
- •oAlanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3 x ULN, or more than 5 x ULN for patients with known liver metastases
- •oTotal bilirubin more than 1.5 x ULN, except for patients with documented Gilbert’s syndrome who are eligible if total bilirubin equal to or less than 3 x ULN
- •11.For participants not taking warfarin or other anticoagulants: international normalised ratio (INR) equal to or more than 1.5 or prothrombin time (PT) equal to or more than 1.5 x ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) equal to or more than 1.5 x ULN. Participants taking warfarin must be on a stable dose that results in a stable INR less than 3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant.
- •12.Major surgery within 28 days prior to the dose of 68Ga-NTA-476. Exceptions may be approved on a case-by-case basis at the principal investigator's discretion, if it is determined not to put the participant at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.
- •13.Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.
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