Fluorescent Guided Surgery in Penile Carcinoma using Cetuximab-800CW

• Conditions: penile cancer; 10040900

• Registration Number: NL-OMON49605
• Lead Sponsor: niversitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 15

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%

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main objective of this feasibility study is to investigate whether<br /><br>cetuximab-800CW could be used for margin assessment during surgery in patients<br /><br>with PSCC.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>