EUCTR2011-003311-27-GB进行中（未招募）1 期
Vascular Targeted Photodynamic therapy with WST11 for T1a Renal Tumours. PHASE IIa histological follow up trial - Vascular Targeted Photodynamic therapy with WST11 for T1a Renal Tumour
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Participant is willing and able to give informed consent for participation in the study. • Male or post-menopausal female, aged 18 years or above. • Lesions suspicious for renal cell carcinoma on triple phase CT that are < 4cm in maximum diameter and suitable for surgical resection • Participant must be in sufficiently good health to be suitable for general anaesthesia for both VTP treatment and subsequent surgical resection of tumour • Subjects must have = 1 evaluable tumours which can be visualised on diagnostic ultrasound. If more than one tumour exists, an index tumour will be nominated and treated (uncommon) • Previous chemotherapy and / or biological therapy for cancer are permitted, but the subject should have recovered fully from the effects of these and any prior surgery (minimum of 28 days). • Patients should not have received radiotherapy to the target area within the preceding 12 months. • Subject has clinically acceptable haematological, electrolyte and hepatic function as demonstrated by serum laboratory values within 14 days prior of VTP treatment: ? Absolute neutrophil count (ANC) = 1500mm-3 ? Platelet count = 100,000mm-3 ? Haemoglobin = 10gdl-1 ? Prothrombin time (PT) = 1.5 * Upper Limit of Normal (ULN) ? Activated partial thomboplastin time (APPT) = 1.5 * ULN ? Total bilirubin < 2.5 * ULN ? Aspartate aminotransferase (AST) < 3 * ULN ? Alkaline phosphatase (ALP) < 2 * ULN; unless arising from bone • Participant has a clinically acceptable ECG • Able (in the Investigators opinion) and willing to comply with all study requirements. • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •Non menopausal women • Significant hepatic impairment. • Significant renal impairment as to mean surgical resection is unsuitable • Clinical or radiological evidence of metastatic disease • Subjects with tumours lying adjacent to vital structures such that VTP treatment would risk damage to these structures • Subjects currently taking immunosuppressive medication • Patients whose medical conditions need the following medication which have potential photosensitising effects (tetracyclines, sulphonamides, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics, amiodarone and griseofulvin) if these treatments cannot be stopped or replaced by other treatments without photosensitizing properties • Patients who have an absolute need for anticoagulant drugs or antiplatelet drugs (e.g., warfarin, aspirin) which cannot be withdrawn during the 10 days prior to the VTP procedure. • Scheduled elective surgery or other procedures requiring general anaesthesia during the study. • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. • Participants involved in the treatment phase of a clinical trial (observational or follow-up studies will be allowed) • An American Society of Anaesthesiologists (ASA) score of = 3 • A World Health Organisation (WHO) performance status of =2
研究者
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