Multispectral optoacoustic imaging using cetuximab-800CW for detection of cervical lymph node metastases: a single center proof of concept study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

In order to be eligible to participate in this study, the subject must meet the inclusion criteria of the ICON study (NCT03134846), which are as follows:
1. Biopsy confirmed diagnosis of primary or recurrent HSCC and scheduled to undergo surgical resection as decided by the Multi-Disciplinary Head & 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

Patients will be excluded when they meet one of the exclusion criteria of the ICON study (NCT03134846), which are as follows:
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 deviations that might lead to cardiac rhythm (grade II or higher deviations by CTCAE);
13. Life expectancy < 12 weeks;
14. Karnofsky performance status < 70%.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Quantification of the cetuximab-800CW optoacoustic signal and the tracer<br /><br>distribution observed by multispectral optoacoustic imaging using the MSOT<br /><br>Acuity Echo in vivo in patients with oral squamous cell carcinoma.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Correlation between optoacoustic signal and fluorescence intensity of<br /><br>cetuximab-800CW in cervical lymph nodes.<br /><br>- Standard histopathological assessment (i.e. hematoxylin and eosin staining)<br /><br>to correlate optoacoustic signal detected in vivo with histology using surgical<br /><br>specimens;<br /><br>- Histopathologic characteristics of surgical specimens related to EGFR-status<br /><br>and tracer distribution.</p><br>