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Arginyl-glycyl-aspartic acid

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

18F labelled Cyclic RGD peptide PET agent for injection.

Fluciclatide Injection - (AH111585 (F18))

Jeffrey Winick, Ph.D.

This proof-of-concept study is designed to assess the ability of \[18F\]AH-111585 PET imaging to detect tumors and angiogenesis. Up to 30 evaluable subjects are planned to be included at up to 2 study centers in the US. Subjects are considered evaluable if they undergo administration of AH-111585 (18F) Injection, dynamic and static PET imaging, and tumor tissue acquisition. The targeted population is adult subjects at initial diagnosis or recurrence with tumors ≥2.5 cm in diameter who are scheduled to undergo resection or biopsy of the tumor as a result of routine clinical treatment. The tumors must belong to one of the following 5 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
* Head and neck (H\&N) tumors, including laryngeal squamous cell carcinoma, well-differentiated thyroid and oral cavity carcinoma
* Sarcoma
* Melanoma

Safety will be assessed from the rates of adverse events, changes in vital signs, changes in electrocardiogram (ECG) parameters, changes in physical examination findings, and changes in clinical laboratory findings.

Efficacy will be assessed as the correlations between parameters derived from the PET images and the reference standards. The reference standards will be immunohistology for αvβ3 integrins and other biomarkers specific for oncology and angiogenesis and from the standard of care imaging.

Measures obtained from optional DCE-CT imaging may also be used to compare the uptake and retention of \[18F\]AH-111585 in tumors obtained from the dynamic PET to assess functional status of the vascular system of the tumor.

A Proof-of-concept Study to Assess the Ability of [18F]AH-111585 PET Imaging to Detect Tumours and Angiogenesis

A Phase 2, Open-label, Proof-of-concept Study to Assess the Ability to Detect Tumours and Angiogenesis Via the Expression of ανβ3/5 Integrin Receptors by [18F]AH-111585 PET Imaging

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 Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. 0.60 to 0.44 equals a moderately positive correlation and 0.33 to 0.37 equals a weak positive correlation.

Two (2) of the 22 subjects did not have any αvβ5 integrin results.

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.

GE Healthcare

The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).

Fluciclatide Injection

Safety With Fluciclatide Injection

Age, Continuous

Age, Categorical

Sex: Female, Male

United States

United Kingdom

Region of Enrollment

33 subjects enrolled/ started the study. 25 subjects were used in this study analysis.

Paul Gordon, PhD

Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.

Correlation Between Ki_inp-Patlak and αvβ3 Optical Density

This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.

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)

Correlation Between VT_inp-Logan and αvβ3 Optical Density

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)

The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). Correlation of the Magnitude of \[18F\]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors for the Full Analysis Set (FAS) subjects.

Correlation Between Ki_inp-Patlak αvβ5 Optical Density

This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.

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)

The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). Correlation of the Magnitude of \[18F\]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.

Correlation Between VT_inp-Logan and αvβ5 Optical Density

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)

Correlation Between SUVw_55 and αvβ3 Optical Density

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)

Correlation Between SUVR_55_blood and αvβ3 Optical Density

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)

Correlation of the Magnitude of \[18F\]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.

This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).

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)

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)

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)

Correlation Between SUVw_55 and αvβ5 Optical Density

Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ5 Optical Density)

Correlation Between SUVR_55_blood and αvβ5 Optical Density

Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ5 Optical Density)

Correlation Between Ki_inp-Patlak and αvβ5 Optical Density

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 and αvβ5 Optical Density)

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