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Sponsored by: |
Siemens Molecular Imaging |
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Information provided by: | Siemens Molecular Imaging |
ClinicalTrials.gov Identifier: | NCT00743353 |
The purpose of this research study is to get information from volunteers without cancer and patients with cancer who have received a new investigational study agent called, "[F-18] RGDK5," to evaluate biodistribution and dosimetry for the study agent and determine F-18 RGD-K5 uptake in angiogenic tumor. the system.
Condition | Intervention | Phase |
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Sarcoma Melanoma Lung Cancer Breast Cancer High Grade Gliomas |
Drug: F-18 RGD-K5 |
Phase 0 |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | An Exploratory, Multi-Center, Open Label, Non-Randomized Study of F-18 RGD-K5 |
Estimated Enrollment: | 16 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
16 subjects to be enrolled; Study Drug F-18 RGD-K5 administered for diagnostic PET Imaging to be observed for a maximum of 4 hours, followed by 24 hour follow up
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Drug: F-18 RGD-K5
Study Drug F-18 RGD-K5 administered for diagnostic PET Imaging to be observed for a maximum of 4 hours, followed by 24 hour follow up
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[F-18]RGD-K5 is being investigated as a diagnostic radiopharmaceutical for the detection and localization of angiogenesis tissue or lesions supporting the application and role of integrins in anti-angiogenic therapies to benefit patients with cancer and inflammatory diseases.
The primary objectives of this exploratory study are:
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
For Normal Volunteers
For Cancer Subjects (same first four bullets as 'normals')
Exclusion Criteria 'Normals':
For Cancer Subjects (first three bullets the same as 'normals')
Contact: James Zhang, MD, PhD, MBA | 610 448-3375 | James.zhang@siemens.com |
Contact: Kathleen Marcozzi Pierce, MA | 610 448-3378 | Kathleen.marcozzi-pierce@siemens.com |
United States, Pennsylvania | |
Fox Chase Cancer Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19111 | |
Contact: Mary Benetz 215-214-3904 Mary.benetz@fccc.edu | |
Principal Investigator: Michael Yu, MD |
Principal Investigator: | Michael Yu, MD | Fox Chase Cancer Center, Dept of Nuclear Medicine, 333 Cottman Ave, Phila, PA 19111 |
Responsible Party: | Global Head of Clinical Development ( James Zhang, MD, PhD, MBA, Senior Director, Medical Monitor ) |
Study ID Numbers: | K5-100 |
Study First Received: | August 26, 2008 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00743353 |
Health Authority: | United States: Food and Drug Administration |
laryngeal squamous cell anaplastic astrocytoma oligodendroglioma glioblastoma multiforme |
Thoracic Neoplasms Glioblastoma Astrocytoma Skin Diseases Malignant mesenchymal tumor Breast Neoplasms Soft tissue sarcomas Neuroendocrine Tumors Melanoma Neuroectodermal Tumors Glioblastoma multiforme |
Respiratory Tract Diseases Lung Neoplasms Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Lung Diseases Sarcoma Neuroepithelioma Oligodendroglioma Nevus Glioma Breast Diseases |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type |
Neoplasms by Site Neoplasms, Nerve Tissue Nevi and Melanomas |