Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Breast Neoplasms

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Carcinoma, Renal Cell

Head and Neck Neoplasms

Glioma

Neoplasms by Histologic Type

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Neoplasms, Glandular and Epithelial

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

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Male Urogenital Diseases

Soft Tissue Sarcoma

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Fluciclatide Injection (AH111585 (18F) Injection)

Fluciclatide Injection

Jeffrey Winick, Ph.D.

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.

Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of (18F) Injection

A Test-retest Study to Assess Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of AH111585 (18F) Injection.

Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions.

Safety was monitored throughout the duration of the subject's participation.

BIAFFIN GmbH & Co. KG (Biomolecular Interaction Analyses)

Quintiles, Inc.

i3 Statprobe

GE Healthcare

1 Fluciclatide Injection

Age, Categorical

Age, Continuous

Sex: Female, Male

India

Korea, Republic of

Sweden

United Kingdom

Region of Enrollment

70 Subjects enrolled. A total of 49 subjects received a least one dose of Fluciclatide administration.

Matthew Miller

40 Minute Post Injection

65 Minute Post Injection

90 Minute Post Injection

Fluciclatide Injection (AH111585 (18F) Injection) at 10mCi \[370 megabecquerels (MBq)\]

Imaging Session 1

Imaging Session 2

The Relative difference between imaging sessions 1 and 2.

Relative Difference

Subjects received 2 doses of Fluciclatide Injection (AH111585 (18F) Injection).

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.

Any TEAE

Total number of TEAEs

Any TEAE at least related to Drug

Intesity-Mild

Intensity-Moderate

Intensity-Severe

Any SAEs

Any SAE at least related to Drug

Any AE leading to Study Discontinuation

Any AE leading to Death

Any AE leading to death at least related to Drug

The number of adverse events in relationship to the categories descrbed using Fluciclatide Injection (AH111585 (18F) Injection).

Number of Adverse Events

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).

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.

AH111585 (18F) Injection : AH111585 (18F) Injection

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of (18F) Injection	NCT00918281	Solid Tumors High Grade Glio... Lung Cancer Head and Neck C... Sarcoma Renal Cell Carc... Breast Cancer	Fluciclatide In...	18 Years -	GE Healthcare
Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of (18F) Injection	NCT00918281	Solid Tumors High Grade Glio... Lung Cancer Head and Neck C... Sarcoma Renal Cell Carc... Breast Cancer	Fluciclatide In...	18 Years -	GE Healthcare

Spots Global Cancer Trial Database for fluciclatide injection