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

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Brief Title

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

Official Title

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

Brief 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.
    

Detailed 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.
    


Study Type

Interventional


Primary Outcome

Optoacoustic signal


Condition

Oral Cancer

Intervention

MSOT Acuity Echo

Study Arms / Comparison Groups

 Study group
Description:  Patients with oral squamous cell carcinoma that have been included in ICON-study and are scheduled for treatment of neck

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

20

Start Date

April 11, 2019

Completion Date

September 30, 2021

Primary Completion Date

July 30, 2021

Eligibility Criteria

        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%.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT03923881

Organization ID

NL67343.042.18


Responsible Party

Principal Investigator

Study Sponsor

University Medical Center Groningen


Study Sponsor

, , 


Verification Date

April 2021