NCT01447134

RGD-K5 in Head and Neck Cancer Patients

Phase II Study of [18F]RGD-K5 in Head and Neck Cancer Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

1. Primary endpoint(s): To determine the relationship between the drug distribution and angiogenesis in head and neck cancer patients. 2. Secondary endpoint(s): To expand the safety database of \[F-18\]RGD-K5 and to correlate the parameters from the image study to clinical treatment response and prognosis.

Detailed description

This is an uncontrolled, open-labeled, non-randomized, prospective study. The study duration is expected to be completed in a period of 3 year. Up to 100 patients would be included. Group A would be those to undergo surgical excision or biopsy (n=20); Group B would be those with N2c-3M0 disease to receive chemotherapy followed by concurrent chemoradiotherapy (n=40); and Group C would be those with M1 disease to receive biotherapy or chemotherapy (n=40). Group A patients could be included into Group B or C if qualified. Each participant must fulfill all the inclusion and exclusion criteria.

Conditions

• Head and Neck Neoplasms

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-06-01
• Completion: 2014-06-01
• First posted: 2011-10-06
• Last updated: 2011-10-06