Clinical trial · Interventional
Image Guided Penile Cancer Surgery
Fluorescent Guided Surgery in Penile Carcinoma Using Cetuximab-800IRDyeCW
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Margin Assessment | — | UNRESOLVED | — |
| Penile Cancer | Malignant Penile Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab-IRDye800CW | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase 1: 75mg Cetuximab and 15mg Cetuximab-IRDye800CW
- description
- Patients receive 75mg of Cetuximab, followed by 15mg Cetuximab-IRDye800CW I.V. two days prior to surgery.
- interventionNames
- Drug: Cetuximab-IRDye800CW
Primary outcomes (1)
- measure
- Phase 1: Compare the spot to background ratio for tumor positive and tumor negative margins.
- timeFrame
- 2 years
- description
- The main purpose is to establish the intraoperative use of cetuximab-800CW as a reliable marker for residual tumor in resection margins after surgical removal of PSCC. The objective is to establish the feasibility of cetuximab-800CW fluorescence at the dose of 75/15 mg predose/dose combination as a marker for a tumor positive resection by comparing the spot to background ratios for tumor positive and tumor negative margins. A tumor to background ratio of \>2.0 is aspired.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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%
References
Publications (0)
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