The main objectives of this study is to evaluate if EGFR positive cervical lymph node metastasis can be detected non-invasively using the MSOT Acuity Echo with cetuximab-800CW as contrast agent in patients with oral squamous cell carcinoma.
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quantification of the cetuximab-800CW optoacoustic signal and the tracer
distribution observed by multispectral optoacoustic imaging using the MSOT
Acuity Echo in vivo in patients with oral squamous cell carcinoma.
Secondary outcome
- Correlation between optoacoustic signal and fluorescence intensity of
cetuximab-800CW in cervical lymph nodes.
- Standard histopathological assessment (i.e. hematoxylin and eosin staining)
to correlate optoacoustic signal detected in vivo with histology using surgical
specimens;
- Histopathologic characteristics of surgical specimens related to EGFR-status
and tracer distribution.
Background summary
The presence of lymph node metastasis is one of the most important prognostic
factors in oral squamous cell carcinoma (OSCC). In addition, it is an important
factor in determining the appropriate treatment plan in patients with OSCC.
However, detection of lymph node metastases by means of current imaging
modalities is limited. 20-30% of patients with a clinically negative neck (cN0)
harbour lymph node metastasis that were not detected during clinical diagnostic
workup, which are referred to as occult lymph node metastasis. Personalized
management of the neck would benefit greatly from staging techniques that
increase the accuracy of the assessment of nodal disease. In addition,
visualizing the pattern of lymphatic spread can possibly lead to more targeted
neck dissections and thereby reduce morbidity. Clearly, there is need for
additional diagnostic tools in order to identify lymph node metastasis and
thereby support the decision making for treatment of the neck.
Optoacoustic imaging is a novel imaging method in which an ultrashort laser
pulse is used to irradiate biological tissue. Consequently, optoacoustic or
photoacoustic waves are generated which can be measured by wideband ultrasonic
transducers. Optoacoustic imaging has been shown to address clinically relevant
aspects of various cancers. It also enables the visualization of targeted
tumor-specific biomarkers by detecting optoacoustic waves. We hypothesize that
accumulation of cetuximab-IRDye800CW can be detected in lymph node metastasis,
enabling better visualization of regional metastatic disease compared to
current imaging modalities. We believe that this approach can improve detection
of lymph node metastases and thereby supports decision making for treatment of
the neck.
Study objective
The main objectives of this study is to evaluate if EGFR positive cervical
lymph node metastasis can be detected non-invasively using the MSOT Acuity Echo
with cetuximab-800CW as contrast agent in patients with oral squamous cell
carcinoma.
Study design
The current study is a single center, prospective, cross-sectional, proof of
concept study. The study will be carried out by the out at the University
Medical Center Groningen, Department of Oral and Maxillofacial Surgery and
Department of Nuclear Medicine and Molecular Imaging. Further analysis of
sections of the lymph node metastasis will be done at the Department of
Pathology.
Study burden and risks
Burden
- Time investment: Patients need to visit the UMCG two to four days before
their planned surgery according to the ICON-study which will take approximately
2 hours. For the imaging that will be performed prior to tracer administration
(part of the ICON study), additional 20-30 minutes are necessary. Usually
patients are admitted one day prior to surgery. Therefore the imaging on this
day will not require extra time investment
- Extra procedures: Two imaging procedures, prior to tracer administration and
on day of admission.
Risks
The optoacoustic imaging device uses a class IV laser and therefore is a risk
for cornea and skin. Several measurements described below, are taken to reduce
the risk of injuries to an absolute minimum.
Benefit
Patients will have no direct benefit from this study.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
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%.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67343.042.18 |