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| Sponsor: | Siemens Molecular Imaging |
|---|---|
| Information provided by: | Siemens Molecular Imaging |
| ClinicalTrials.gov Identifier: | NCT00743353 |
Purpose
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 |
|---|---|---|
|
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 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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
|
[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:
Eligibility| 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')
Contacts and Locations| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Principal Investigator: | Michael Yu, MD | Fox Chase Cancer Center, Dept of Nuclear Medicine, 333 Cottman Ave, Phila, PA 19111 |
More Information
| 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: | January 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00743353 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
laryngeal squamous cell anaplastic astrocytoma oligodendroglioma glioblastoma multiforme |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Skin Diseases Neoplasms, Nerve Tissue Breast Neoplasms Melanoma Neuroendocrine Tumors Neoplasms, Connective and Soft Tissue Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Lung Diseases Sarcoma Nevi and Melanomas Breast Diseases |