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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluciclatide Injection - (AH111585 (F18)) | Experimental | Using of the drug product named, AH111585 (F18) Injection. It's generic chemical name is Fluciclatide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluciclatide Injection - (AH111585 (F18)) | Drug | 18F labelled Cyclic RGD peptide PET agent for injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. | 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 αvβ3 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ3 Optical Density) | 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. | 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 αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density) | 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. | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. |
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Selection of Subjects: The targeted subject population is adult subjects at initial diagnosis or recurrence with tumours ≥2.5 cm in diameter who are scheduled to undergo resection or biopsy of the tumour as a result of routine clinical treatment.
General Inclusion Criteria for all Subjects:
Inclusion Criteria Specific for Subjects with High-grade Glioma:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Winick, Ph.D. | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare Office | Princeton | New Jersey | 08540 | United States |
33 subjects enrolled,16 subjects completed and 17 did not complete. The reasons why 17 subjects that did not complete the study: 2 subjects failed screening, 6 subjects were lost to followup, 1 subject the procedure had technical problems, 2 subjects discontinued due to Physician decision, and 6 subjects had other reasons for not completing.
A total of 33 subjects enrolled in this study. 16 subjects completed the study and 17 subjects did not.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluciclatide Injection | The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 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. |
| 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 αvβ3 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ3 Optical Density) | 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. | 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 αvβ3 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ3 Optical Density) | 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. | 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 αvβ3 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density) | 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. | 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 αvβ3 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ3 Optical Density) | 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. | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
| 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) | 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. | 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 SUVw_55 and αvβ5 Optical Density) | 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. | 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 SUVR_55_blood and αvβ5 Optical Density) | 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. | 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 Ki_inp-Patlak and αvβ5 Optical Density) | 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. | 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) | 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. | 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 SUVw_55 and αvβ5 Optical Density) | 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. | 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 SUVR_55_blood and αvβ5 Optical Density) | 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. | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
| COMPLETED |
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| NOT COMPLETED |
|
|
33 subjects enrolled/ started the study. 25 subjects were used in this study analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety With Fluciclatide Injection | The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 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. | This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results. | Posted | Number | 95% Confidence Interval | Correlation coefficient | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
|
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| Primary | 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) | 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. | This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results. | Posted | Number | 95% Confidence Interval | Correlation coefficient | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
|
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| Secondary | 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) | 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. | This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results. | Posted | Number | 95% Confidence Interval | Correlation coefficient | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
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| Secondary | 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 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. | This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results. | Posted | Number | 95% Confidence Interval | Correlation coefficient | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
|
| ||||||||||||||||||||||||||
| Primary | 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 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. | This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results. | Posted | Number | 95% Confidence Interval | Correlation coefficient | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
|
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| Primary | 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 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. | This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results. | Posted | Number | 95% Confidence Interval | Correlation coefficient | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
|
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| Primary | 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 by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively. | This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC). | Posted | Number | 95% Confidence Interval | Correlation coefficient | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
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| Primary | 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) | 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. | This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC). | Posted | Number | 95% Confidence Interval | Correlation coefficient | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
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| Primary | 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 by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively. | This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC). | Posted | Number | 95% Confidence Interval | Correlation coefficient | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
|
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| Primary | 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 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. | This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC). | Posted | Number | 95% Confidence Interval | Correlation coefficient | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
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| Secondary | 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 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. | This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results. | Posted | Number | 95% Confidence Interval | Correlation coefficient | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
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| Secondary | 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 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. | This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results. | Posted | Number | 95% Confidence Interval | Correlation coefficient | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
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| Secondary | 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) | 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. | This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC). | Posted | Number | 95% Confidence Interval | Correlation coefficient | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
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| Secondary | 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 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. | This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC). | Posted | Number | 95% Confidence Interval | Correlation coefficient | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
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| Secondary | 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 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. | This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC). | Posted | Number | 95% Confidence Interval | Correlation coefficient | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
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| Secondary | 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 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. | This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC). | Posted | Number | 95% Confidence Interval | Correlation coefficient | Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. |
|
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Up to 6 weeks post administration of Fluciclatide (GE-135) (18F) Injection at 10 mCi [370 megabecquerels (MBq)].
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluciclatide Injection | The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). | 5 | 25 | 13 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Glioblastoma Multiforme (GBM) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Idiopathic Thrombocytopenic Purpura (ITP) | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Renal Injury | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Subcutaneous Emphysema | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment | AEs were described by system organ class. |
|
| General disorders and administration site conditions | General disorders | MedDRA (12.0) | Systematic Assessment | AEs were described by system organ class. |
|
| Infections and Infestations | Infections and infestations | MedDRA (12.0) | Systematic Assessment | AEs were described by system organ class. |
|
| Investigations | Investigations | MedDRA (12.0) | Systematic Assessment | AEs were described by system organ class. |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment | AEs were described by system organ class. |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Gordon, PhD | GE Healthcare | 011-47-2318-5822 | paul.gordon@ge.com |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D008175 | Lung Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D012509 | Sarcoma |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D018358 | Neuroendocrine Tumors |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C530281 | AH 111585 |
Not provided
Not provided
Not provided
| >=65 years |
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