Overview

Image Guided Penile Cancer Surgery

Status:
Recruiting

Trial end date:
2025-03-01

Target enrollment:
0

Participant gender:
All

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 margins are an independent risk factor for local recurrence, which has been reported to be up to 18%. Tumor-positive margins always lead to extra, penile sparing surgery, which leads to longer hospitalization, higher exposure to anesthetic interventions and a worse psychological outcome. Currently, no intraoperative imaging technique that provides real time feedback for resection margins exists in PSCC. Molecular fluorescence-guided Surgery (MFGS) using targeted near-infrared (NIR) optical contrast agents like for example Cetuximab-800CW is a promising technique to accommodate this need. Epidermal Growth Factor Receptor (EGFR) is overexpressed in PSCC and has safely and successfully been used as target for molecular imaging, particularly for assessment for tumor margins in head and neck squamous cell carcinoma (ICON study, UMCG1).

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University Medical Center Groningen

Collaborator:

Erasmus Medical Center

Treatments:

Cetuximab

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%