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

GE Healthcare Ltd0 个研究点目标入组 45 人开始时间: 2010年3月18日最近更新: 2014年1月27日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 45

研究概览入排标准研究者记录与标识符相似试验

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

性别: All

入选标准

•The subject has been diagnosed with at least 1 solid primary or metastatic tumor at least 2.0 cm in diameter, including but not limited to NSCLC, RCC, GBM, melanoma, sarcoma, H&N, and breast cancers.
•The subject is undergoing therapy for a malignant tumour with non-curative intent.
•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.
•The subject has the following baseline serum biochemisty and haematology values: blood urea nitrogen (BUN) value and serum creatinine (sCr) value of less 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 more than 9 g/dL; and platelet count of more than 75,000 x 10E+6/L.
•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 2.
•Endocrine therapy is permitted provided that it has been initiated for more than a month prior to first AH111585 imaging session and treatment continues at least through the second AH111585 imaging session.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

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 between the first and second [18F]AH111585 PET scans.
•The subject’s target tumour has been biopsied less than 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

研究者

发起方

GE Healthcare Ltd

相似试验

进行中（未招募）

1 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) InjectioAdult subjects with solid primary or metastatic tumours 2 cm or more in diameter. Malignancies may include but are not limited to non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), glioblastoma multiforme (GBM), melanoma, sarcoma, head and neck (H&N), and breast cancers.

EUCTR2008-003835-18-GBGE Healthcare Ltd45

已完成

2 期

CTRI/2010/091/001052GE Healthcare Pvt Ltd45

进行中（未招募）

1 期

Effects of maintenance cabozantinib+BSC versus BSC in children and AYA withosteosarcoma. ( CabOSTar )

CTIS2023-506229-12-00Ipsen Innovation71

招募中

不适用

A randomized open-label phase 2 study to evaluate the efficacy between only radiotherapy versus combination therapy with radiotherapy and temozolomideNeoplasms

KCT0000700Asan Medical Center104

进行中（未招募）

1 期

EUCTR2009-012460-14-GBGlaxoSmithKline Biologicals376