Title
Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of (18F) Injection
A Test-retest Study to Assess Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of AH111585 (18F) Injection.
Phase
Phase 2Lead Sponsor
General ElectricStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Solid Tumors High Grade Gliomas Lung Cancer Head and Neck Cancer Sarcoma Renal Cell Carcinoma Breast CancerIntervention/Treatment
Fluciclovine ...Study Participants
70Study aimed to assess the reproducibility of PET imaging using AH111585 (18F) Injection. Subjects are evaluable if they undergo 2 administrations of AH111585 (18F) Injection (3 to 8 days apart) and the corresponding PET acquisitions, and tumors demonstrate detectable levels of 18F uptake on PET.
Fluciclatide Injection (AH111585 (18F) Injection)
Inclusion Criteria: The subject has been diagnosed with at least one solid primary or metastatic tumor greater than 2.0 cm in diameter, including but not limited to NSCLC, RCC, GBM, melanoma, sarcoma, breast and H&N cancers. The subject has received clinical routine imaging diagnostic work-up within 8 weeks prior to the first [18F]AH111585 PET scan. The subject has a clinically acceptable (as judged by the investigator) physical examination at screening and is capable of self-care. Exclusion Criteria: The subject has known hyper- or hypo-coagulation syndromes. The subject has received chemotherapy within 3 weeks, or received radiotherapy, surgery or any other treatment against cancer 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 is scheduled to undergo biopsy for the target tumour between the first and second [18F]AH111585 PET scans. The subject has intra-hepatic tumour(s) only. For the immuno-histochemistry group, the subject's target tumour has been biopsied less than or equal to 1 week prior to the first [18F]AH111585 PET scan.
| Event Type | Organ System | Event Term | 1 Fluciclatide Injection |
|---|
Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions.
Safety was monitored throughout the duration of the subject's participation.
