Phase II Study of [18F]RGD-K5 in Head and Neck Cancer Patients
20 Years
N/A
Both
Head and Neck Neoplasms
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
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
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Authority:
Taiwan: Department of Health
Study ID:
IRB99-3338A
NCT ID:
NCT01447134
Start Date:
June 2011
Completion Date:
June 2014
Related Keywords:
- Head and Neck Neoplasms
- Neoplasms
- Head and Neck Neoplasms
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