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RGD-K5 in Head and Neck Cancer Patients

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01447134
Enrollment
100
Registered
2011-10-06
Start date
2011-06-30
Completion date
2014-06-30
Last updated
2011-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Neoplasms

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.

Interventions

None listed

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026