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

20 Years
Open (Enrolling by invite only)
Head and Neck Neoplasms

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Time Perspective: Prospective


Taiwan: Department of Health

Study ID:




Start Date:

June 2011

Completion Date:

June 2014

Related Keywords:

  • Head and Neck Neoplasms
  • Neoplasms
  • Head and Neck Neoplasms