Clinical trial · Interventional
MSOT Using Cetuximab-800CW for Detection of Cervical Lymph Node Metastases
Multispectral Optoacoustic Imaging Using Cetuximab-800CW for Detection of Cervical Lymph Node Metastases: a Single Center Proof of Concept Study
- 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 presence of lymph node metastasis 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. Therefore, patients with a risk of lymph node metastasis higher than 20% undergo a sentinel node procedure (SNP) or elective neck dissection (END), which means that a substantial part of patients is overtreated. There is need for an additional non-invasive diagnostic tool that can identify lymph node metastasis and thereby support the decision making for treatment of the neck. The main objective of this study is to evaluate if EGFR-positive cervical lymph node metastasis can be detected non-invasively with multispectral optoacoustic imaging using cetuximab-800CW as contrast agent in patients with oral squamous cell carcinoma.
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 |
|---|---|---|---|
| Lymph Node Metastases | — | UNRESOLVED | — |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MSOT Acuity Echo | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study group
- description
- Patients with oral squamous cell carcinoma that have been included in ICON-study and are scheduled for treatment of neck
- interventionNames
- Device: MSOT Acuity Echo
Primary outcomes (1)
- measure
- Optoacoustic signal
- timeFrame
- A week after imaging is performed
- description
- The optoacoustic signal intensity in lymph nodes compared to surrounding tissue
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: patients must meet inclusion criteria of the ICON study (NCT03134846), which are as follows: * Biopsy confirmed diagnosis of primary or recurrent HNSCC and scheduled to undergo surgical resection as decided by the Multi-Disciplinary Head \& Neck Tumor Board of the UMCG. * Age ≥ 18 years * Written informed consent * Adequate potential for follow up * Acceptable hematologic status, kidney function, and liver function, as standard surgery protocol requires. Exclusion Criteria:patients must meet exclusion criteria of the ICON study (NCT03134846), which are as follows: * Medical or psychiatric conditions that compromise the patient's ability to give informed consent; * Concurrent uncontrolled medical conditions; * Received an investigational drug within 30 days prior to the dose of cetuximab-800CW; * Tumors at sites of which the surgeon would assess that in vivo imaging would not be feasible; * Had within 6 months prior to enrollment: myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease, unstable angina; * Inadequately controlled hypertension with or without current antihypertensive medications; * History of infusion reactions to cetuximab or other monoclonal antibody therapies * 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; * Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females); * Lab values that in the opinion of the primary surgeon would prevent surgical resection; * Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents; * Magnesium, potassium and calcium deviations that might lead to cardiac rhythm (grade II or higher deviations by CTCAE); * Life expectancy \< 12 weeks; * Karnofsky performance status \< 70%.
References
Publications (0)
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