Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT05376202
Eligibility Criteria:
Inclusion Criteria:
1. Biopsy confirmed diagnosis of primary or recurrent PSCC and scheduled to undergo surgical resection of primary or recurrent tumor with or without (sentinel) lymph node procedure as decided by the Urology Department of the UMCG.
2. Age ≥ 18 years
3. Written informed consent
4. Adequate potential for follow-up
Exclusion Criteria:
1. Medical or psychiatric conditions that compromise the patient's ability to give informed consent
2. Concurrent uncontrolled medical conditions
3. Received an investigational drug within 30 days prior to the dose of cetuximab-800CW
4. Tumors at sites of which the surgeon would assess that in vivo imaging would not be feasible
5. Had within 6 months prior to enrollment: myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease, unstable angina
6. Inadequately controlled hypertension with or without current antihypertensive medications
7. History of infusion reactions to cetuximab or other monoclonal antibody therapies
8. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
9. Lab values that in the opinion of the primary surgeon would prevent surgical resection
10. Patients receiving Class Ia (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
11. Magnesium, potassium and calcium deviations that might lead to cardiac rhythm (grade II or higher deviations by CTCAE)
12. Life expectancy \< 12 weeks
13. Karnofsky performance status \< 70%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05376202
Study Brief:
Protocol Section:
NCT05376202