Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Fluciclatide Injection - (AH111585 (F18)), Fluciclatide Injection, AH111585 (18F) Injection
Fluciclatide · 2 trials · 10 indications
Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions.
Correlation of the Magnitude of \[18F\]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. 0.22 and 0.24 equals a weak positive correlation and 0.16 and 0.18 equals a negligible correlation. Three (3) of the 22 subjects did not have any αvβ3 integrin results. Ki-inp-Patlak is a graphical analysis technique based on the compartment model that uses linear regression to identify and analyze pharmacokinetics of tracers involving irreversible uptake.
Correlation of the Magnitude of \[18F\]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. The Logan plot is the counterpart of the Patlak plot for reversible radiotracers.
Correlation of the Magnitude of \[18F\]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. SUVw\_55 is the standard uptake value at 55 minutes post-injection, normalized to weight.
Correlation of the Magnitude of \[18F\]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively. Twelve (12) of the 22 subjects had renal cell carcinoma (RCC) the remaining subjects did not have RCC. SUVR\_55\_blood is the standard uptake value ratio (tumor-to-blood) at 55 minutes post-injection.
Correlation of the Magnitude of \[18F\]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Correlation of the Magnitude of \[18F\]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Correlation of the Magnitude of \[18F\]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
| Arm | Type | Description |
|---|---|---|
| Fluciclatide Injection | EXPERIMENTAL | Fluciclatide Injection |
| Fluciclatide Injection - (AH111585 (F18)) | EXPERIMENTAL | Using of the drug product named, AH111585 (F18) Injection. It's generic chemical name is Fluciclatide. |
| Name | Type | Description |
|---|---|---|
| Fluciclatide Injection | DRUG | Fluciclatide Injection (AH111585 (18F) Injection) |
| Fluciclatide Injection - (AH111585 (F18)) | DRUG | 18F labelled Cyclic RGD peptide PET agent for 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 ...
Fluciclatide is an investigational PET imaging agent being studied in oncology for visualizing solid tumors and high-grade gliomas. It is designed to help detect tumors and angiogenesis, the formation of new blood vessels that supports tumor growth, using positron emission tomography following intravenous administration.
Fluciclatide is being developed by GE HealthCare Technologies Inc., which trades on the Nasdaq under the ticker GEHC. The company is the sponsor behind the clinical studies evaluating this imaging agent in cancer patients.
Fluciclatide is in Phase 2 clinical development. It is an investigational imaging agent and has not been approved by the FDA. The completed Phase 2 studies were designed to assess its imaging performance in patients with solid tumors and high-grade gliomas.
Fluciclatide has been evaluated in two completed Phase 2 trials. NCT00918281 studied the reproducibility of 18F uptake by solid tumors using PET imaging in 70 patients. NCT00565721 was a proof-of-concept study assessing the ability of [18F]AH-111585 PET imaging to detect tumors and angiogenesis in 33 patients.
Yes. Fluciclatide is also known as AH111585 (F18) and is referred to as Fluciclatide Injection. These names describe the same fluorine-18 labeled PET imaging agent developed by GE HealthCare Technologies Inc. for oncology imaging applications.
Fluciclatide is a small molecule peptide, or -tide, based imaging agent. It is used in PET imaging to visualize tumor tissue and angiogenesis in cancers including high-grade glioma, lung cancer, head and neck cancer, sarcoma, melanoma, renal cell carcinoma, and breast cancer.