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Fluciclatide

Phase 2

High-grade Glioma | Small molecule | Oncology |GE HealthCare Technologies Inc.|Last Updated: Aug 18, 2014

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

Fluciclatide · 2 trials · 10 indications

Phase 2 2
NCT00918281Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of (18F) InjectionSolid Tumors
COMPLETED70 Analytics
NCT00565721A Proof-of-concept Study to Assess the Ability of [18F]AH-111585 PET Imaging to Detect Tumours and AngiogenesisHigh-grade Glioma
COMPLETED33 Analytics
PHASE2COMPLETED
Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of (18F) Injection
Solid TumorsUnlock trial analytics
PHASE2COMPLETED
A Proof-of-concept Study to Assess the Ability of [18F]AH-111585 PET Imaging to Detect Tumours and Angiogenesis
High-grade GliomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging.
Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration.

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 With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ3 Optical Density)
Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

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 With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ3 Optical Density)
Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

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 With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density)
Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

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 With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ3 Optical Density)
Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

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 With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ3 Optical Density)
Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

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 With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density)
Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

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 With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ3 Optical Density)
Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

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.

Secondary Endpoints

The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.
Up to 8 weeks post contrast administration.
Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak αvβ5 Optical Density)
Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ5 Optical Density)
Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Fluciclatide InjectionEXPERIMENTALFluciclatide Injection
Fluciclatide Injection - (AH111585 (F18))EXPERIMENTALUsing of the drug product named, AH111585 (F18) Injection. It's generic chemical name is Fluciclatide.

Interventions

NameTypeDescription
Fluciclatide InjectionDRUGFluciclatide Injection (AH111585 (18F) Injection)
Fluciclatide Injection - (AH111585 (F18))DRUG18F labelled Cyclic RGD peptide PET agent for injection.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 ...

Countries:United States
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Frequently asked questions about Fluciclatide

What is Fluciclatide used for?

Fluciclatide is an investigational small molecule being studied for use in oncology, specifically in solid tumors and high-grade glioma. It is a PET imaging agent designed to detect tumors and angiogenesis. Fluciclatide is currently in Phase 2 clinical development and is not yet approved by the FDA.

What does Fluciclatide target?

Fluciclatide is a small molecule PET imaging agent that targets angiogenesis, the process of new blood vessel formation in tumors. It is designed to detect tumors and angiogenesis in conditions such as high-grade glioma, lung cancer, head and neck cancer, sarcoma, and melanoma. The specific molecular target is not disclosed.

Who makes Fluciclatide?

Fluciclatide is being developed by GE HealthCare Technologies Inc., a company publicly traded under the ticker symbol GEHC. The drug is currently in Phase 2 clinical trials for oncology indications, including solid tumors and high-grade glioma.

What phase is Fluciclatide in?

Fluciclatide is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 2 trials have been completed, with a total enrollment of 70 participants across studies for solid tumors, high-grade glioma, and other cancer types.

What clinical trials is Fluciclatide in?

Fluciclatide has been studied in two completed Phase 2 clinical trials. NCT00565721 assessed its ability to detect tumors and angiogenesis in conditions including high-grade glioma, lung cancer, head and neck cancer, sarcoma, and melanoma. NCT00918281 evaluated the reproducibility of 18F uptake in solid tumors and other cancers.

Is Fluciclatide the same as [18F]AH-111585?

Yes, Fluciclatide is also known as [18F]AH-111585. In clinical trials, it is referred to as an (18F) injection for PET imaging. The drug is being investigated for its ability to detect tumors and angiogenesis in various cancer types, including solid tumors and high-grade glioma.