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Sponsored by: |
GE Healthcare |
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Information provided by: | GE Healthcare |
ClinicalTrials.gov Identifier: | NCT00565721 |
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:
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.
Condition | Intervention |
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High-Grade Glioma Lung Cancer Head & Neck Cancer Sarcoma Melanoma |
Drug: [18F]AH-111585 |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Phase 2, Open-Label, Proof-of-Concept Study to Assess the Ability to Detect Tumours and Angiogenesis Via the Expression of ανβ3/5 Integrin Receptors by [18F]AH-111585 PET Imaging |
Fresh Frozen and paraffin embedded sectioned samples from resected or biopsied tumor tissue in slide format; whole blood samples; separated serum samples
Estimated Enrollment: | 30 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | August 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
The targeted subject population is adult subjects at initial diagnosis or recurrence with tumours ≥2.5 cm in diameter who are scheduled to undergo resection or biopsy of the tumour as a result of routine clinical treatment.
Selection of Subjects: The targeted subject population is adult subjects at initial diagnosis or recurrence with tumours ≥2.5 cm in diameter who are scheduled to undergo resection or biopsy of the tumour as a result of routine clinical treatment.
General Inclusion Criteria for all Subjects:
Inclusion Criteria Specific for Subjects with High-grade Glioma:
Exclusion Criteria:
Contact: Jeffrey Winick, Ph.D. | 609-514-6728 | Jeffrey.Winick@ge.com |
United States, New Jersey | |
GE Healthcare Office | Recruiting |
Princeton, New Jersey, United States, 08540 | |
Contact: Jeffrey Winick, Ph.D. 609-514-6728 Jeffrey.Winick@ge.com |
Study Director: | Jeffrey Winick, Ph.D. | GE Healthcare |
Responsible Party: | GE Healthcare ( Jeffrey Winick, Ph.D./Study Director ) |
Study ID Numbers: | GE-135-003 |
Study First Received: | November 28, 2007 |
Last Updated: | November 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00565721 |
Health Authority: | United States: Food and Drug Administration |
Static PET imaging Dynamic PET imaging Angiogenesis αvβ3 integrins oncology imaging |
Thoracic Neoplasms Malignant mesenchymal tumor Soft tissue sarcomas Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Respiratory Tract Diseases Lung Neoplasms |
Head and Neck Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Sarcoma Neuroepithelioma Glioma Nevus |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type |
Neoplasms by Site Neoplasms, Nerve Tissue Nevi and Melanomas |