Adult 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.
Conditions
Interventions
Sponsors
GE Healthcare Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 AH111585imaging 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the test-retest reproducibility of [18F]AH111585 uptake by solid tumours following intravenous administration of AH111585 (18F) Injection.; Secondary Objective: (1) To assess the image quality and lesion detectability of [18F]AH111585 as a function of administered activity, by temporal segmentation (2) To assess the safety of 2 or more administrations, each of a maximum of 370 MBq, AH111585 (18F) Injection in subjects with solid primary or metastatic tumours. (3) To assess the relationship between 18F uptake by solid tumours and avb3 expression and other histological markers of angiogenesis in pre- or post- imaging biopsy material. ; Primary end point(s): Efficacy: Assessment of the test-retest reproducibility will be based on measurements obtained for each targeted tumour lesion and the extent of the difference between Standardized Uptake Value (SUV) measurements of [18F]AH111585 uptake following AH111585 (18F) Injection administration and PET imaging on 2 separate days within an interval of 3-8 days. Safety: Physical examinations, Vital signs, Serum biochemistry, Haematology, Coagulation parameters, 12 lead ECG, Anti-AH111585 antibody evaluation, Pre-treatment and Post treatments events (AEs and SAEs). | — |
Countries
Sweden, United Kingdom
Outcome results
None listed