Status:
COMPLETED
Image Guided Penile Cancer Surgery
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Erasmus Medical Center
Conditions:
Penile Cancer
Margin Assessment
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The main treatment modality for Penile Squamous Cell Carcinoma (PSCC) is surgery with curative intent. In organ sparing surgery a tumor-positive margin of up to 36% exist. Tumor-positive surgical marg...
Detailed Description
The main treatment modality for Penile Squamous Cell Carcinoma (PSCC) is surgery with curative intent. There is no difference in mortality between organ sparing surgery and radical surgery, and for op...
Eligibility Criteria
Inclusion
- 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.
- Age ≥ 18 years
- Written informed consent
- Adequate potential for follow-up
Exclusion
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- Concurrent uncontrolled medical conditions
- Received an investigational drug within 30 days prior to the dose of cetuximab-800CW
- Tumors at sites of which the surgeon would assess that in vivo imaging would not be feasible
- Had within 6 months prior to enrollment: myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease, unstable angina
- Inadequately controlled hypertension with or without current antihypertensive medications
- History of infusion reactions to cetuximab or other monoclonal antibody therapies
- Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
- Lab values that in the opinion of the primary surgeon would prevent surgical resection
- Patients receiving Class Ia (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- Magnesium, potassium and calcium deviations that might lead to cardiac rhythm (grade II or higher deviations by CTCAE)
- Life expectancy \< 12 weeks
- Karnofsky performance status \< 70%
Key Trial Info
Start Date :
March 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05376202
Start Date
March 7 2022
End Date
April 14 2024
Last Update
April 19 2024
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713GZ