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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03923881
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
dr. M.J.H. Witjes, University Medical Center Groningen

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.


Condition or disease Intervention/treatment Phase
Oral Cancer Lymph Node Metastases Device: MSOT Acuity Echo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 20 patients that have been included in the ICON-study (NCT03134846) and therefore will be administered with cetuximab-800CW
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multispectral Optoacoustic Imaging Using Cetuximab-800CW for Detection of Cervical Lymph Node Metastases: a Single Center Proof of Concept Study
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: Study group
Patients with oral squamous cell carcinoma that have been included in ICON-study and are scheduled for treatment of neck
Device: MSOT Acuity Echo
Optoacoustic imaging with the MSOT Acuity Echo
Other Name: Administration of cetuximab-800CW as part of the ICON-study (NCT03923881)




Primary Outcome Measures :
  1. Optoacoustic signal [ Time Frame: A week after imaging is performed ]
    The optoacoustic signal intensity in lymph nodes compared to surrounding tissue



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923881


Locations
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Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713GZ
Contact: Max JH Witjes, PhD    +315036 ext 13841    m.j.h.witjes@umcg.nl   
Contact: Jasper Vonk, BSc    +315036 ext 14518    j.vonk@umcg.nl   
Sponsors and Collaborators
University Medical Center Groningen

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Responsible Party: dr. M.J.H. Witjes, Principal Investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03923881    
Other Study ID Numbers: NL67343.042.18
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by dr. M.J.H. Witjes, University Medical Center Groningen:
Multispectral Optoacoustic Tomography
Molecular Imaging
Cetuximab-800CW
Additional relevant MeSH terms:
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Neoplasm Metastasis
Mouth Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents