ISRCTN91527768已完成2 期
Extra-corporeal high intensity focused ultrasound for primary sacrococcygeal bone tumours: Phase IIb trial of clinical efficacy
Oxford University Hospitals NHS trust (UK)0 个研究点目标入组 20 人开始时间: 2013年6月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
- 性别
- All
入选标准
- •1. Participant is willing and able to give informed consent for participation in the study
- •2. Male or Female, aged 18 years or above
- •3. Lesions must be histologically verified as primary bone tumours of the spine either by prior radiologically-guided biopsy or by histological examination of prior surgically resected samples of the tumour
- •4. Participant must be in sufficiently good health to be suitable for general anaesthesia for both EC-HIFU treatment (generally ASA grade 1 or 2)
- •5. 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)
- •6. Previous surgical resection and/or chemotherapy therapy for the primary bone tumour are permitted, but the subject should have recovered fully from the effects of these and the interventions should have been completed more than 12 months from the commencement
- •of HIFU. Previous spinal fixation as part of the procedure to remove the original tumour will not be an exclusion criterion in itself, but if at the planning stage the fixation device interferes with treatment delivery, the patient may fail pre-assessment and be excluded from the trial
- •7. Patients should not have received radiotherapy to the target area within the preceding 12 months
- •8. Subject has clinically acceptable haematological, electrolyte and hepatic function as demonstrated by serum laboratory values within 14 days prior to EC-HIFU treatment:
- •8.1. Absolute neutrophil count (ANC) = 1500mm-3
- •8.2. Platelet count = 100,000mm-3
- •8.3. Haemoglobin = 10gdl-1
- •8.4. Prothrombin time (PT) = 1.5 * Upper Limit of Normal (ULN)
- •8.5. Activated partial thomboplastin time (APTT) = 1.5 * ULN
- •8.6. Total bilirubin < 2.5 * ULN
- •8.7. Aspartate aminotransferase (AST) < 3 * ULN
- •8.8. Alkaline phosphatase (ALP) < 2 * ULN; unless arising from bone
- •9. Participants have a clinically acceptable ECG
- •10. Negative pregnancy test within 24 hours of EC-HIFU treatment (if appropriate)
- •11. Able (in the Investigators opinion) and willing to comply with all study requirements
- •12. Willing to allow his or her General Practitioner and referring Consultant, if appropriate, to be notified of participation in the study, and be contacted 5 years after treatment to assess survival
- •13. A World Health Organisation (WHO) performance status of = 1
排除标准
- •1. Female participants who are pregnant, lactating or planning pregnancy during the course of the study (see pregnancy test note above)
- •2. Significant hepatic impairment
- •3. Significant renal impairment
- •4. Scheduled elective surgery or other procedures requiring general anaesthesia within a period of 8 weeks after finishing HIFU treatment
- •5. 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.
- •6. Participants currently involved in any medicinal trial
- •7. Participants involved in the treatment phase of a clinical trial (observational or follow-up studies will be allowed)
- •8. If, during the planning stage, it is adjudged by the planning team that treatment to the tumour may pose an unacceptable risk to the patient?s life or health, for example if a segment of bowel is likely to be damaged by the HIFU beam, the patient will be excluded. In this circumstance the patient?s intention to participate in the trial will be recorded in the CRF and the technical reason for exclusion recorded. Patients excluded from the trial for technical reasons will be reported in future analyses to help scrutinising clinicians decide
- •on the viability of HIFU as a treatment.
研究者
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