INCLUSION CRITERIA:
General inclusion criteria for all subjects:
Subjects may be included in the study if they meet all of the following criteria:
(1) The subject is greater than or equal to 18 years old.
(2) The subject has been diagnostically imaged and is suspected of having a primary or metastatic tumour lesion greater than or equal to 2.5 cm of one of the following types:
-High-grade glioma, including glioblastoma multiforme, anaplastic astrocytoma, and anaplastic oligodendroglioma
-Lung cancer, including small cell lung cancer and non-small cell lung cancer
-H& N tumours, including laryngeal squamous cell carcinoma, and well-differentiated thyroid and oral cavity carcinoma
-Sarcoma
-Melanoma
(3) The subject is scheduled to undergo resection or biopsy of the greater than or equal to 2.5 cm target tumor 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 AH-111585 (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 less than or equal to 1.5 of the upper normal limit.
(8) The subject has a platelet count of greater than 75,000 times 10(6)/L.
(9) The subject has a haemoglobin value of greater than 9 g/dL.
(10) The subject has a prothrombin time and a PTT 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 complete the study.
(12) The subject has not received any anti-angiogenic agents (e.g. bevacuzimab, sorafenib, sunitinib) within 10 days prior to PET imaging.
(13) The subject has had no open wounds within 10 days prior to study entry.
(14) The chosen target tumor is not within the liver.
This study is designed to include women and minorities. Men and women will be recruited with no preference to gender. No exclusion from this study will be based on race.
Inclusion criteria specific for subjects with suspected or previously diagnosed high-grade glioma:
Subjects may be included in the study if they meet all of the criteria in Section 7.2.1 along with the following criteria:
(1) 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.
(2) 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 14 days of entry into the study.
EXCLUSION CRITERIA:
Subjects must be excluded from participating in this study if they meet any of the following criteria:
(1) The subject is lactating.
(2) The subject is being treated with heparin or coumadin.
(3) The subject has received another IMP within 14 days before, or will receive an IMP within 1 week after administration of AH-111585 (18F) injection.
(4) The subject was previously included in this study.
(5) The subject experienced substantial changes in their medical status before all essential study procedures (including all imaging procedures and surgical excision or biopsy) are performed.
(6) The subject has any contraindication to any of the study procedures, products used or its constituents (e.g. X-ray contrast media).
(7) 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.
(8) The subject is unable to lie down for 125 minutes.
(9) The subject suffers from claustrophobia.
(10) The subject has known diagnosis of human immunodeficiency virus (HIV) infection.
(11) The subject has known diagnosis of hepatitis B or C infection.
(12) The subject has known diagnosis of mental incapacitation and it affects their ability to consent.
(13) The subject has a history of serious hypersensitivity reaction to iodinated contrast media.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 11/25/2009