Image Guided Surgery for Margin Assessment of Head and Neck Cancer Using Cetuximab-IRDye800CW cONjugate

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Surgery remains a main pillar in the treatment of head and neck squamous cell carcinoma (HNSCC). The margin status is the main prognostic factor of local tumor control in surgically treated HNSCC and will determine the postoperative treatment strategy. A margin of ≤1 mm of normal tissue is considered a positive margin and requires either a re-operation or postoperative chemoradiation with a combination of cisplatin and 5-FU, which substantially increases morbidity. Margins wider than 1 mm but less than 5 mm require re-operation, or, if that is not possible, post-operative radiotherapy without the concomitant use of chemotherapy. Currently, no technology is available in the operating room, which reliably supports tumor excision in terms of margin status. In fact, surgeons can only combine pre- operative imaging data with tactile and visual information during surgery for assessing tumor margins with limited accuracy. With the introduction of molecular imaging techniques using near infrared (NIR) fluorescent optical contrast agents coupled to targeted compounds, new avenues have opened up for intra-operative assessment of tumor margins. Tracers are based on antibodies directed against Vascular Endothelial Growth Factor-A, i.e. bevacizumab-IRDye800CW, in patients with breast cancer or against Epidermal Growth Factor Receptor, i.e. cetuximab-IRDye800CW, in patients with HNSCC. First trials have shown that systemic administration of these compounds is safe and tumor specific. These findings prompted us to design this innovative application in a clinical trial for the intraoperative assessment of tumor margins during surgical treatment of HNSCC using cetuximab-IRDye800CW.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborators: Erasmus Medical Center; UMC Utrecht
• Treatments: Cetuximab

Criteria

Inclusion criteria

1. Biopsy confirmed diagnosis of primary or recurrent HNSCC and scheduled to undergo surgical resection as decided by the Multi-Disciplinary Head and Neck Tumor Board of the UMCG.

2. Age ≥ 18 years

3. Written informed consent

4. Adequate potential for follow up

5. Acceptable hematologic status, kidney function, and liver function, as standard surgery protocol requires.

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-IRDye800CW

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. Pregnant or lactating women. Documentation of a negative pregnancy test must be available for women of childbearing potential. Woman of childbearing potential are premenopausal women with intact reproductive organs and women less than two years after menopause.

9. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)

10. Lab values that in the opinion of the primary surgeon would prevent surgical resection.

11. Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.

12. Magnesium, potassium and calcium lower than the lower limit of normal range.

13. Life expectancy < 12 weeks

14. Karnofsky performance status < 70%