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

Study Overview
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Brief Summary
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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.

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

Conditions
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Solid Tumors, High Grade Gliomas, Lung Cancer, Head and Neck Cancer, Sarcoma, Renal Cell Carcinoma, Breast Cancer

Intervention / Treatment
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* Drug: Fluciclatide Injection


Participation Criteria
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Eligibility Criteria
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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 within 8 weeks prior to the first [18F]AH111585 PET scan. The subject has a clinically acceptable (as judged by the investigator) physical examination at screening and is capable of self-care. Exclusion Criteria: The subject has known hyper- or hypo-coagulation syndromes. The subject has received chemotherapy within 3 weeks, or received radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to the first [18F]AH111585 PET scan. The subject is scheduled to undergo chemotherapy, radiotherapy, surgery or any other treatment against cancer between the first and second [18F]AH111585 PET scans. The subject is scheduled to undergo biopsy for the target tumour between the first and second [18F]AH111585 PET scans. The subject has intra-hepatic tumour(s) only. For the immuno-histochemistry group, the subject's target tumour has been biopsied less than or equal to 1 week prior to the first [18F]AH111585 PET scan.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluciclatide Injection<br>Fluciclatide Injection | Drug: Fluciclatide Injection<br>* Fluciclatide Injection (AH111585 (18F) Injection)<br>* Other names: AH111585 (18F) Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. |