A Phase 2, Open-label, Proof-of-concept Study to Assess the Ability to Detect Tumours and Angiogenesis via the Expression of avb3 Integrin Receptors by [18F]AH111585 PET Imaging

Phase 1

• Conditions: lung cancer, including SCLC and NSCLC; Adult subjects with Primary or metastatic tumour lesion of one of the following types: high-grade glioma, including GBM, anaplastic astrocytoma, and anaplastic oligodendroglioma; H&N tumours, including laryngeal squamous cell carcinoma, and well-differentiated thyroid and oral cavity carcinoma; sarcoma; and melanoma; or having a primary or metastatic RCC tumour.

• Registration Number: EUCTR2008-005219-16-GB
• Lead Sponsor: GE Healthcare Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-11
• Study Completion: 2011-09-26
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- The subject has been diagnostically imaged and is suspected of having a primary or metastatic tumour lesion of one of the following types: high-grade glioma, including GBM, anaplastic astrocytoma, and anaplastic oligodendroglioma; lung cancer, including SCLC and NSCLC; H&N tumours, including laryngeal squamous cell carcinoma, and well-differentiated thyroid and oral cavity carcinoma; sarcoma; and melanoma; or having a primary or metastatic RCC tumour.
- The subject’s tumour is greater than or equal to 2.0cm in diameter except for thyroid carcinoma (greater than or equal to 1.5 cm).
- The chosen target tumour is not within the liver.
- The subject is scheduled to undergo resection or biopsy of the target tumour as a result of routine clinical treatment.
- The subject is scheduled to undergo or has received standard of care diagnostic imaging work-up (following the study centre’s routine procedures), e.g. CT with or without contrast, MRI with or without contrast, bone scintigraphy, X-ray, or FDG-PET.
- The subject has the following baseline laboratory parameters: blood urea nitrogen (BUN) value and serum creatinine (sCr) value of less than or equal to 1.5 of the upper normal limit; prothrombin time (PTT) and an activated partial thromboplastin time (aPTT) within normal limits; platelet count of greater than or equal to 150,000 x 10exp6/L; and haemoglobin value of greater than 9 g/dL.
- The subject has a clinically acceptable (as judged by the investigator) physical examination at screening and is capable of self-care, i.e. Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 2, such that the subject has a high chance to complete the study.
- The subject has not received any anti-angiogenic agents (e.g. bevacuzimab, sorafenib, sunitinib) within 60 days prior to PET imaging.
- Female subjects need to be either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), or if of childbearing potential the results of a serum pregnancy test performed within 24 hours must be negative and with the result known before administration of AH111585 (18F) Injection. Female subjects of reproductive potential should also employ an effective method of birth control. Barrier contraceptives must be used throughout the study in both sexes.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- The subject has received another investigational medicinal product (IMP) within 14 days before, or will receive an IMP within 1 week after administration of AH111585 (18F) Injection.
- 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 has known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C infection.
- The subject is unable to lie down for 125 minutes.
- The subject is being treated with heparin or coumadin.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified