No registrations found.
ID
Source
Brief title
Health condition
Squamous Cell Carcinoma of the Oral Cavity
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Mean tumor-to-background ratio (TBR)
2. Rate of adequate (i.e. >5mm clear) tumor resection margins
Secondary outcome
1. Sensitivity, specificity, positive and negative predictive values
2. Co-localization of FLI with immunohistochemistry on pathology slides
3. Percentage of extra tissue resection based on FLI-driven frozen sections
4. Operation time
5. FLI of lymph node metastases after neck dissection
Background summary
Head and neck cancer (HNC) is the 9th most common tumor worldwide, a third of them arising in the oral cavity. Complete tumor resection of oral cancer is the most important surrogate marker for survival. Precise margin delineation is imperative in the delicate head and neck region where wider resections inevitably lead to increased morbidity and loss of functionality.
In current practice, intraoperative assessment of the tumor-free margin is dependent on visual appearance and palpation of the tumor. We have reported inadequate surgical margins in up to 85% of patients with oral cancer, which is unacceptable. Therefore, new intraoperative visualization techniques are required to assess tumor margins in real-time and to guide surgical removal of oral cancer with adequate tumor-free margins while retaining maximal functionality.
Fluorescence imaging (FLI) using near-infrared light has recently emerged as a revolutionary technique to provide real-time visualization of tumor tissue, enabling image-guided surgery. Tumor-specific fluorescent targeting agents are systemically injected preoperatively and real-time FLI is performed using a dedicated intraoperative camera system. In this study, we will test the use of cRGD-ZW800-1, a tumor-specific agent that targets integrins, for intraoperative detection and margin delineation of oral cancer. Overexpression of a wide range of integrin receptors is reported in HNC.
The overarching goal of this two-staged clinical trial is to improve adequate resection of oral cancer.
Study objective
This clinical trial will determine the optimal dose of cRGD-ZW800-1 and investigate the feasibility of intraoperative FLI to adequately assess tumor margins in patients with oral cancer.
Study design
-
Intervention
cRGD-ZW800-1 injection prior to surgery
Inclusion criteria
1) Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;
2) ≥ 18 years of age;
3) Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
4) Screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits, they are considered to be clinically insignificant;
5) The patient has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening;
6) Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Exclusion criteria
1) Previous surgery, chemotherapy or radiotherapy to the oral cavity;
2) History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.
3) Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
4) Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives.
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 | NL8049 |
| Other | METC EMC : 12175 |