RGD-K5 in Head and Neck Cancer Patients

Study Overview
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Brief Summary
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Primary endpoint(s): To determine the relationship between the drug distribution and angiogenesis in head and neck cancer patients. 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
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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.

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

Conditions
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Head and Neck Neoplasms

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical<br>Group (a) [Those to undergo surgical excision or biopsy] patients will receive RGD-K5 scan within two weeks of conventional image evaluations. The image result will be confirmed with histopathological results. | |
| Chemotherapy concurrent Radiation<br>Group (b) patients [Those with N2c-3M0 disease to receive chemotherapy followed by concurrent chemoradiotherapy] will receive RGD-K5 scan prior to beginning of the therapy, after induction chemotherapy, within two weeks after concurrent chemoradiotherapy and two months after completion of concurrent chemoradiotherpy; all within two weeks of conventional image evaluations. | |
| RGD-K5 scan<br>Group (c) patients [Those with M1 disease to receive biotherapy or chemotherapy] will receive RGD-K5 scan prior to the beginning of the first line systemic therapy, two weeks after beginning of the first line systemic therapy, within two weeks of first response evaluation for the first line systemic therapy, and within two weeks after end of the first line systemic therapy; each RGD-K5 scan would be performed within two weeks of conventional image studies. The systemic therapy might be biotherapy or chemotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |