RGD-K5 in Head and Neck Cancer Patients

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01447134
• Other study ID #: IRB99-3338A
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 4, 2011
• Last updated: October 5, 2011
• Start date: June 2011
• Est. completion date: June 2014

Study information

• Verified date: October 2011
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital