RGD-K5 in Head and Neck Cancer Patients

• Conditions: Head and Neck Neoplasms

• Registration Number: NCT01447134
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

Study Timeline

• Study Start: 2011-06
• Status Verified: 2011-10
• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-05
• Last Update Submitted: 2011-10-05
• Study First Posted: 2011-10-06
• Last Update Posted: 2011-10-06
• Primary Completion: 2013-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Head and neck cancer patients (including nasopharyngeal cancer)
• Age equals or more than 20 years old
• Referred by Chang Gung Memorial Hospital (CGMH) Head and Neck Oncology team.
• Willing to sign the informed consent

Exclusion Criteria

• Patient who is pregnant or lactating;
• Patients with a concomitant or previous 2nd primary cancer other than head and neck malignancy;
• Unable to tolerate MR or PET/CT scan, such as those with magnetic implants (e.g. those received intracranial aneurysm surgery, cardiac pacemaker, artificial valves replacement, artificial ears), poor blood sugar control (fasting sugar more than 200 mg/dl), claustrophobia, unable to lie still.
• Unable to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified