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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
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 2.
- •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.
研究者
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
进行中（未招募）
不适用
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) InjectioEUCTR2008-003835-18-SEGE Healthcare 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 temozolomideNeoplasmsKCT0000700Asan Medical Center104
进行中（未招募）
1 期
A phase II, open-label, randomised study to assess the safety and immunogenicity of a birth dose of GSK Biologicals’ reduced-antigen-content tri-component pertussis vaccine followed by routine paediatric vaccination at 2, 4, 6 and 12-18 months of age, and to explore the ability of this schedule to accelerate the acquisition of pertussis antibodies. - PA-TRICOMP-005Primary and booster immunisation of healthy infants in the first two years of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, rotavirus and pneumococcal diseases.MedDRA version: 12.1Level: LLTClassification code 10043376Term: TetanusMedDRA version: 12.1Level: LLTClassification code 10013023Term: DiphtheriaMedDRA version: 12.1Level: LLTClassification code 10034738Term: PertussisMedDRA version: 12.1Level: LLTClassification code 10019731Term: Hepatitis BMedDRA version: 12.1Level: LLTClassification code 10036012Term: PoliomyelitisMedDRA version: 12.1Level: LLTClassification code 10018952Term: Haemophilus influenzae infectionMedDRA version: 12.1Level: LLTClassification code 10067470Term: Rotavirus infectionMedDRA version: 12.1Level: LLTClassification code 10061353Term: Pneumococcal infectionEUCTR2009-012460-14-GBGlaxoSmithKline Biologicals376