| Inclusion Criteria: | 1) The subject is >/= 18 years old.
2) The subject has been diagnostically imaged and is suspected of having a primary or metastatic tumour lesion of one of the following types: a) High-grade glioma, including glioblastoma multiforme, anaplastic astrocytoma, and anaplastic oligodendroglioma b) Lung cancer, including SCLC and NSCLC c) H&N tumours, including laryngeal squamous cell carcinoma, and well differentiated thyroid and oral cavity carcinoma d) Sarcoma e) Melanoma f) Renal Cell Carcinoma
3) The subject is scheduled to undergo resection or biopsy of the target tumour as a result of routine clinical treatment.
4) The subject is scheduled to undergo or has received standard of care diagnostic imaging work-up (following the study centre's routine procedures), e.g. CT with or without contrast, MRI with or without contrast, bone scintigraphy, X-ray, or FDG-PET.
5) Female subjects need to be either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), or if of childbearing potential the results of a serum pregnancy test performed within 24 hours must be negative and with the result known before administration of AH111585 (18F) Injection. Female subjects of reproductive potential should also employ an effective method of birth control. Barrier contraceptives must be used throughout the study in both sexes.
6) The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained.
7) The subject has a blood urea nitrogen value and serum creatinine value of </= 1.5 of the upper normal limit.
8) The subject has a platelet count of >150,000 x 10^6/L.
9) The subject has a haemoglobin value of >9 g/dL.
10) The subject has a prothrombin time (PTT) and aPTT within normal limits
11) 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 performance status is 0 to 2, such that the subject has a high chance to completing the study.
12) The subject has not received any anti-angiogenic agents (e.g. bevacuzimab, sorafenib, sunitinib) within 60 days prior to PET imaging.
13) For subjects with suspected or previously diagnosed high-grade glioma, the subject is suspected of having supratentorial malignant primary glioma (by biopsy or presenting MRI characteristics as determined by the subject's clinician) requiring further surgical resection as part of the recommended treatment plan for their newly diagnosed disease. These gliomas include glioblastoma multiforme, anaplastic astrocytoma, and anaplastic oligodendroglioma.
14) For subjects with suspected or previously diagnosed high-grade glioma, the subject has undergone recent biopsy of newly diagnosed high-grade glioma, has recovered from the effects of surgical biopsy, and baseline on-study MRI/CT is performed within 28 days of entry into the study.
15) For subjects with suspected or previously diagnosed renal cell carcinoma (RCC), the subject has been diagnostically imaged and is suspected of having a primary or metastatic RCC tumour lesion
16) For subjects with suspected or previously diagnosed renal cell carcinoma (RCC), the subject is scheduled to undergo resection or biopsy of the target tumour as a result of routine clinical treatment.
17) The chosen target tumour is not within the liver.
18) The subject has had no open wounds within 10 days prior to study entry.
19) The subject's tumour is ³2.0cm in diameter except for thyroid carcinoma (³1.5 cm). |