head and neck cancer head and neck squamous cell carcinoma
Conditions
Interventions
Administration of a single injection of 2 mg 124I-F16SIP, i.v.
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with previously untreated head and neck cancer scheduled for surgery 2. Histologically/cytologically confirmed diagnosis of cancer.
Exclusion criteria
Exclusion criteria: 1. 1. Chemotherapy, radiation, hormone therapy (with the exception of a gradual titration of LHRH agonists) or immunotherapy or participation in any investigational drug study within 4 weeks of study entry (6 weeks in case of prior nitroureas chemotherapy). 2. Prior radiation dose > 30% of bone marrow volume. 3. Presence of cirrhosis or active hepatitis. 4. Presence of serious cardiac (congestive heart failure, heart insufficiency > grade II NYHA, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The tumor targeting performance of the human radiolabeled antibody 124I-F16SIP. Pharmacokinetics/-dynamics of 124I-F16SIP, and its uptake in tumor and normal tissues as obtained from the surgical specimen. | — |
Secondary
| Measure | Time frame |
|---|---|
| Dosimetric parameters for tumor, bone marrow and normal organs. | — |
Countries
Netherlands
Outcome results
None listed