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

Completed · Phase 2

Conditions studied: High-grade Glioma, Lung Cancer, Head & Neck Cancer, Sarcoma, Melanoma

In brief

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.

Key facts

Study ID

NCT00565721

Run by

GE Healthcare

People needed

33

Starts

2007-11-01

Expected to finish

2012-09-01

Last updated by the study team

2014-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• The subject is lactating.
• The subject is being treated with heparin or coumadin.
• The subject has received another investigational medicinal product (IMP) within 14 days before, or will receive an IMP within 1 week after administration of AH-111585 (18F) Injection.
• The subject was previously included in this study.
• The subject experienced substantial changes in their medical status before all essential study procedures (including all imaging procedures and surgical excision or biopsy) are performed.
• The subject has any contraindication to any of the study procedures, products used or its constituents (e.g. X-ray contrast media).
• The subject has known hyper- or hypo-coagulation syndromes. Such coagulopathies include but are not limited to Von Willebrand disease, Protein C deficiency, Protein S deficiency, Hemophilia A/B/C, Factor-V Leiden, and Bernard-Soulier syndrome.
• The subject is unable to lie down for 125 minutes.
• The subject suffers from claustrophobia.
• The subject has known diagnosis of human immunodeficiency virus (HIV) infection.
• The subject has known diagnosis of hepatitis B or C infection.
• The subject has known diagnosis of mental incapacitation and it affects their ability to consent.
• The subject has been diagnosed with a primary or metastatic tumour lesion <2.5 cm.

Where it is running

• GE Healthcare Office — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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