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

NCT03923881 | Unknown

• 1 other identifier: NL67343.042.18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cancer; Lymph Node Metastases

Keywords

Multispectral Optoacoustic Tomography; Molecular Imaging; Cetuximab-800CW

Outcome Measures

Primary Outcomes (1)

• Optoacoustic signal

  The optoacoustic signal intensity in lymph nodes compared to surrounding tissue

  A week after imaging is performed

Study Arms (1)

Study group

EXPERIMENTAL

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

Device: MSOT Acuity Echo

Interventions

MSOT Acuity Echo DEVICE

Optoacoustic imaging with the MSOT Acuity Echo

Also known as: Administration of cetuximab-800CW as part of the ICON-study (NCT03923881)

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Mouth Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 20 patients that have been included in the ICON-study (NCT03134846) and therefore will be administered with cetuximab-800CW

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 23, 2019
• Study Start: April 11, 2019
• Primary Completion: July 30, 2021
• Study Completion: September 30, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)