MSOT Using Cetuximab-800CW for Detection of Cervical Lymph Node Metastases — OPUS  

Oral Cancer Clinical Trial

Official title: Multispectral Optoacoustic Imaging Using Cetuximab-800CW for Detection of Cervical Lymph Node Metastases: a Single Center Proof of Concept Study

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Background: 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. 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 by enabling visualization of targeted tumor-specific biomarkers by detecting optoacoustic waves. We hypothesize that accumulation of cetuximab-800CW can be detected in lymph node metastasis, enabling better visualization of regional metastatic disease compared to current imaging modalities. This approach can improve detection of lymph node metastases and thereby supports decision making for treatment of the neck.

Objectives: The main objective 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 population: 20 patients with oral squamous cell carcinoma that have been included in the ICON-study (NCT03134846) and are scheduled for treatment of the neck will be included.

Patient related study procedures: Prior to tracer administration as part of the ICON study, optoacoustic imaging is performed. Two-four days later, surgical procedure will take place. One day prior to surgery, the patient is admitted to the hospital and optoacoustic imaging is performed with cetuximab-800CW as contrast agent.

Main study endpoints: Quantification of the cetuximab-800CW optoacoustic signal and tracer distribution observed by multispectral optoacoustic imaging using the MSOT Acuity Echo in vivo in patients with oral squamous cell carcinoma.

Burden, risks and benefit to participation: Time investment: Patients need to visit the UMCG 2-4 days before their planned surgery according to the ICON-study which will take approximately 2 hours. For the first imaging session, the imaging procedure will take 20-30 minutes and therefore the visit is prolonged with 20-30 minutes. Usually patients are admitted one day prior to surgery. Therefore the second imaging on this day will not require extra time investment, although the imaging procedure takes 20-30 minutes Extra procedures: Two imaging procedures, prior to tracer administration and on day of admission. Both imaging procedures will take 20-30 minutes.

Several measures described below have been taken to reduce the risk of injuries to an absolute minimum. The residual risk of MSOT is slight, reversible reddening and temperature increase of the skin.

Patients will have no direct benefit from this study. ;

Related Conditions & MeSH terms

• Lymph Node Metastases
• Mouth Neoplasms
• Neoplasm Metastasis
• Oral Cancer

• NCT number: NCT03923881
• Study type: Interventional
• Source: University Medical Center Groningen
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2019
• Completion date: September 30, 2021