NCT00743353

Exploratory, Phase 0 Study of Positron Emission Tomography (PET) Imaging Agent, F-18 RGD-K5

An Exploratory, Multi-Center, Open Label, Non-Randomized Study of F-18 RGD-K5

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Siemens Molecular Imaging · Industry
• Sex: All
• Age: 18 Days
• Healthy volunteers: Accepted

Summary

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.

Detailed description

\[F-18\]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: * To gain information on biodistribution of \[F-18\]RGD-K5, and to evaluate the PET images with \[F-18\]RGD-K5 for resolution, signal to background ratio and for the detection and localization of angiogenesis tissue. This Exploratory Investigational New Drug (EIND) study is designed to obtain preliminary imaging and fundamental biodistribution, metabolism and safety information to demonstrate early proof of concept. The information collected under this study will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management for the subject.

Conditions

• Sarcoma
• Melanoma
• Lung Cancer
• Breast Cancer
• High Grade Gliomas

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-08-28
• Last updated: 2009-02-02

Locations

1 site across 1 country: United States