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| Name | Class |
|---|---|
| BIAFFIN GmbH & Co. KG (Biomolecular Interaction Analyses) | UNKNOWN |
| Quintiles, Inc. | INDUSTRY |
| i3 Statprobe | INDUSTRY |
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Study 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluciclatide Injection | Experimental | Fluciclatide Injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluciclatide Injection | Drug | Fluciclatide Injection (AH111585 (18F) Injection) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions. | Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Safety was monitored throughout the duration of the subject's participation. | Up to 8 weeks post contrast administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Winick, Ph.D. | GE Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 101 Carnegie Center | Princeton | New Jersey | 08540 | United States |
Due to the number of subjects that did not complete this study, additional subjects were enrolled bring to total enrolment to 70 subjects.
70 Subjects started and enrolled in this study. 41 Subjects completed this study and 29 did not complete this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Fluciclatide Injection | AH111585 (18F) Injection : AH111585 (18F) Injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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70 Subjects enrolled. A total of 49 subjects received a least one dose of Fluciclatide administration.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Fluciclatide Injection | Fluciclatide Injection (AH111585 (18F) Injection) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | 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. | Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions. | Subjects received 2 doses of Fluciclatide Injection (AH111585 (18F) Injection). | Posted | Mean | Standard Deviation | Standardized Uptake Value | Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration. |
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| Secondary | 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. | Safety was monitored throughout the duration of the subject's participation. | The variable is looking at the Overall Summary of Treatment-Emergent Adverse Events (TEAE). Subjects could have experienced more than one TEAE. The category titles refer to Severe Adverse Events(SAE) and Adverse Events (AE). | Posted | Number | number of adverse events | Up to 8 weeks post contrast administration. |
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Data was collected up to 8 weeks post contrast drug administration.
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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 | 1 Fluciclatide Injection | Fluciclatide Injection (AH111585 (18F) Injection) | 7 | 49 | 3 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower respiratory Tract Infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Carcinoma / Metastases | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
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| Spinal Cord Compression | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Lymphadenectomy | Surgical and medical procedures | MedDRA 13.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Miller | GE Healthcare | 011-44-1494-543981 | matthew.miller@ge.com |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D012509 | Sarcoma |
| D002292 | Carcinoma, Renal Cell |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C530281 | AH 111585 |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Sweden |
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| United Kingdom |
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| 90 Minute Post Injection |
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