Oral CancerOPUSNCT03923881
MSOT Using Cetuximab-800CW for Detection of Cervical Lymph Node Metastases
A study testing MSOT Acuity Echo in people with Oral Cancer and Lymph Node Metastases, run by University Medical Center Groningen at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer, Lymph Node Metastases
- What is being tested?
- MSOT Acuity Echo
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Apr 2019to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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%.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713GZ
Max JH Witjes, PhD, +315036 ext. 13841, m.j.h.witjes@umcg.nl
Jasper Vonk, BSc, +315036 ext. 14518, j.vonk@umcg.nl
About this study
Official title: Multispectral Optoacoustic Imaging Using Cetuximab-800CW for Detection of Cervical Lymph Node Metastases: a Single Center Proof of Concept Study
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.
Read the 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.
- Conditions
- Oral Cancer, Lymph Node Metastases
- Being tested
- MSOT Acuity Echo
- Keywords
- Multispectral Optoacoustic Tomography, Molecular Imaging, Cetuximab-800CW
- Medical subject headings
- Mouth Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSOT Acuity EchoDevice
Also called Administration of cetuximab-800CW as part of the ICON-study (NCT03923881)
Optoacoustic imaging with the MSOT Acuity Echo
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients with oral squamous cell carcinoma that have been included in ICON-study and are scheduled for treatment of neck Receives: Device: MSOT Acuity Echo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optoacoustic signal
The optoacoustic signal intensity in lymph nodes compared to surrounding tissue
Measured: A week after imaging is performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start11 Apr 2019
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. M.J.H. Witjes, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923881
- Sponsor's protocol ID
- NL67343.042.18
- Acronym
- OPUS
- Status last verified
- Apr 2021
- First submitted
- 17 Apr 2019
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multispectral Optoacoustic Imaging Using Cetuximab-800CW for Detection of Cervical Lymph Node Metastases: a Single Center Proof of Concept Study
- ClinicalTrials.gov ID
- NCT03923881
- Acronym / sponsor ID
- OPUS / NL67343.042.18
- Conditions
- Oral Cancer, Lymph Node Metastases
- Keywords
- Multispectral Optoacoustic Tomography, Molecular Imaging, Cetuximab-800CW
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 20 patients that have been included in the ICON-study (NCT03134846) and therefore will be administered with cetuximab-800CW
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: MSOT Acuity EchoPatients with oral squamous cell carcinoma that have been included in ICON-study and are scheduled for treatment of neck |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSOT Acuity EchoAlso: Administration of cetuximab-800CW as part of the ICON-study (NCT03923881)Optoacoustic imaging with the MSOT Acuity Echo | Device | Study group |
Primary outcome
Optoacoustic signal
Time frame: A week after imaging is performed
The optoacoustic signal intensity in lymph nodes compared to surrounding tissue
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSOT Acuity Echo in people with Oral Cancer and Lymph Node Metastases, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optoacoustic signal (time frame: A week after imaging is performed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.