No registrations found.
ID
Source
Brief title
Health condition
Cutaneous squamous cell carcinoma
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Macroscopic fluorescent signal levels (TBR) and tracer distribution observed by NIR
fluorescence imaging using the intraoperative in vivo imaging as well as the ex vivo backtable
imaging;
- Quantification of fluorescent signals using MDSFR/SFF spectroscopy;
- Standard histopathological assessment (i.e. haematoxylin and eosin staining) to correlate
fluorescent and non-fluorescent areas detected in vivo with histology using surgical
specimen;
Secondary outcome
- Histopathologic examinations related to ex vivo EGFR expression and cetuximab-
IRDyeCW800 distribution.
- Quantification of the cetuximab-800CW optoacoustic signal and the tracer distribution
observed by multispectral optoacoustic imaging using the MSOT Acuity Echo in vivo.
Background summary
The gold standard of treatment in non-melanoma skin cancer (NMSC) is surgical excision, for which micrographic surgery techniques are developed to ensure the complete removal of tumor tissue, while maximizing normal tissue conservation. Mohs Micrographic Surgery (MMS) is recommended for high-risk and recurrent basal cell carcinoma, cutaneous squamous cell carcinoma (cSCC) and other uncommon skin tumors. Although MMS is beneficial for precise margin assessment, it is time-consuming and labor-intensive. The preparation usually takes 20 to 60 minutes per excision, during which the patient waits, and the entire cycle is repeated until a tumor free plane is achieved. Moreover, the size of the tumor limits the indication for MMS. There is need for an instrument that can reliably support
tumor excision with 100% margin control in a ‘real-time’ manner, irrespectively to the size and origin of the tumor.
Molecular fluorescence guided surgery enables the visualization of targeted tumor-specific biomarkers by using fluorescence, thereby enhancing the contrast between tumor and normal tissue. The objective of this feasibility study is to determine if the intravenously administered conjugate cetixumab-IRDye800CW can be used for intraoperative margin assessment during MMS in patients with cutaneous squamous cell carcinoma.
Study objective
Image guided surgery using cetuximab-IRDye800CW enables margin assessment during Mohs micrographic surgery.
Study design
The primary objectives of this study are studied during and immediately after surgery
Intervention
Intravenous injection of an unlabeled predose (cetuximab) and cetuximab-IRDye800CW two days prior to surgery. During surgery, fluorescence imaging will be performed.
Inclusion criteria
1) Biopsy confirmed diagnosis of cSCC and scheduled to undergo surgical resection
using MMS;
2) Age ≥ 18 years;
3) Written informed consent;
4) Mentally competent person showing adequate potential for follow-up;
For female subjects who are of childbearing potential, are premenopausal with intact
reproductive organs or are less than 2 years post-menopausal:
5) A negative serum or urine pregnancy test prior to receiving the tracer.
6) Willing to ensure that she or her partner uses effective contraception during the trial
and for 6 months thereafter.
Exclusion criteria
1) Medical or psychiatric conditions that compromise the patient’s ability to give informed
consent;
2) Concurrent uncontrolled medical conditions.
3) Received an investigational drug within 30 days prior to the dose of cetuximab-
IRDye800CW;
4) Tumors at sites of which the surgeon would assess that in vivo imaging would not be
feasible;
5) Had within 6 months prior to enrollment: myocardial infarction, cerebrovascular
accident, uncontrolled cardiac heart failure, significant liver disease, unstable angina;
6) Inadequately controlled hypertension with or without current antihypertensive
medications;
7) History of infusion reactions to cetuximab or other monoclonal antibody therapies
8) Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or
greater than 450 ms in females);
9) Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide,
amiodarone, sotalol) antiarrhythmic agents;
10) Magnesium, potassium and calcium deviations that might lead to cardiac rhythm
(grade II or higher deviations by CTCAE).
11) Life expectancy < 26 weeks;
12) Karnofsky performance status < 70%.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7828 |
| Other | METC UMCG : METC 2019/183 |