CTRI/2010/091/001052已完成2 期
A phase 2, open-label test-retest study to assess the reproducibility of quantitative measurements of 18F uptake by solid tumours using PET imaging following intravenous administration of AH111585 (18F) Injection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- To assess the test-retest reproducibility of [18F]AH111585 uptake by solid tumors following intravenous administration of AH111585 (18F) Injection via PET imaging.
研究概览
简要总结
This will be a global study in up to 15 centres. The objective of the study is to assess the test-retest reproducibility of PET imaging using AH111585 (18F) Injection. Assessment of the test-retest reproducibility will be on measurements obtained for each targeted tumor lesion and the extent of the difference between SUV measurements of AH111585 (18F) uptake following injection of AH111585 (18F). Patients are evaluable if they undergo 2 administrations of AH111585 (18F) Injection (3 to 8 days apart) and the corresponding PET acquisitions. A total of up to 35 patients from India could be included in the study as per the approval from DCGI. Date of enrollment for Indian patients will occur after 01 October 2010.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Â·The subject has been diagnosed with at least one solid primary or metastatic tumor greater than or equal to 2.0 cm in diameter, including but not limited to NSCLC, RCC, GBM, melanoma, sarcoma, H&N, and breast cancers.
- •Â·The subject is undergoing therapy for a malignant tumour with non-curative intent.
- •Â·The subject has received clinical routine imaging diagnostic work-up (e.g., CT with or without contrast,magnetic resonance imaging [MRI] with or without contrast, bone scintigraphy, X-ray, Mammography, [18F] FDG PET) within 8 weeks prior to the first [18F]AH111585 PET scan.
- •Â·The subject has the following baseline serum biochemistry and haematology values: blood urea nitrogen (BUN) value and serum creatinine (sCr) value of less than or equal to 1.5 of the upper normal limit; prothrombin time (PTT) and activated partial thromboplastin time (aPTT) within normal limits; haemoglobin value of >9 g/dL;and platelet count of >75,000 x 106/L.
- •Â·The subject has a clinically acceptable (as judged by the investigator) physical examination at screening and is capable of self-care, i.e. Eastern Cooperative Oncology Group (ECOG) performance status is 0 to
- •Â·Endocrine therapy is permitted provided that it has been initiated greater than or equal to 1 month prior to the first AH111585 imaging therapy and the treatment continues at least through the second AH111585 imaging session.
排除标准
- •·The subject has received another IMP within 30 days before the first administration of AH111585 (18F) Injection, will receive another IMP during or between the 2 administrations of AH111585 (18F) Injection or plans to receive an IMP within 1 week after the second administration of AH111585 (18F) Injection.·The subject has known hyper- or hypo-coagulation syndromes.
- •Such coagulopathies include but are not limited to Von Willebrand disease, Protein C deficiency, Protein S deficiency, Haemophilia A/B/C, Factor-V Leiden, and Bernard-Soulier syndrome.·The subject has received chemotherapy within 2 weeks, or received radiotherapy, surgery or any other treatment against cancer (with the exception of endocrine therapy) within 4 weeks prior to the first [18F]AH111585 PET scan.·The subject is scheduled to undergo chemotherapy, radiotherapy, surgery or any other treatment against cancer (with the exception of endocrine therapy) between the first and second [18F]AH111585 PET scans.·The subject's target tumour has been biopsied <4 weeks prior to the first [18F]AH111585 PET scan (not applicable for the immuno-histochemistry group) or is scheduled to undergo biopsy for the target tumour between the first and second [18F]AH111585 PET scans.
- •Subjects in the immuno-histochemistry group may not have had the target tumour biopsied less than or equal to 1 week prior to the first [18F]AH111585 PET scan.·The subject has intra-hepatic tumour(s) only (without extra-hepatic tumour).·The subject has known diagnosis of human immunodeficiency virus (HIV) infection or hepatitis B-or C-type virus infection.·The subject is being treated with heparin or warfarin.
结局指标
主要结局
To assess the test-retest reproducibility of [18F]AH111585 uptake by solid tumors following intravenous administration of AH111585 (18F) Injection via PET imaging.
时间窗: Imaging takes approximately 65 minutes per imaging session
次要结局
- To assess the image quality and lesion detectability of [18F]AH111585 as a function of administered(activity, by temporal segmentation.)
研究者
研究点 (2)
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