Squamous Cell Carcinoma of the Head and Neck Clinical Trial
— GuidedbyLightOfficial title:
Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging
This is a two-staged clinical trial to investigate the feasibility of intraoperative Fluorescence Imaging (FLI) to adequately assess tumor margins in patients with oral cancer using cRGD-ZW800-1.
Status | Recruiting |
Enrollment | 28 |
Est. completion date | March 1, 2025 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. 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. Patients with renal insufficiency (eGFR<60); 5. Patients with a previous kidney transplantation in the medical history; 6. Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired on weakened immune system, caused by either a pre-existing disease or concomitant medications; 7. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Erasmus University Medical Center | Rotterdam | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | WP-I: (Highest) mean tumor-to-background ratio (TBR) | Two dosages of cRGD-ZW800-1 are tested in two groups of each 7 patients. An expansion cohort (n=14) will be added to the dose group that yields the highest TBR. | up to 48 ours post-dose | |
Primary | WP-II: Rate of adequate (i.e. >5mm clear) tumor resection margins. | through histopathology, up to max 4 weeks post-op | ||
Secondary | WP-II: Sensitivity, specificity, positive and negative predictive values | through histopathology, up to max 4 weeks post-op | ||
Secondary | WP-II: Co-localization of FLI with immunohistochemistry on pathology slides | through histopathology, up to max 4 weeks post-op | ||
Secondary | WP-II: Percentage of extra tissue resection based on FLI-driven frozen sections | through histopathology, up to max 4 weeks post-op | ||
Secondary | WP-II: Operation time | through histopathology, up to max 4 weeks post-op | ||
Secondary | WP-II: FLI of lymph node metastases after neck dissection | through histopathology, up to max 4 weeks post-op |
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