cancer squamous cell carcinoma of the larynx- and hypopharynx
Conditions
Interventions
Patients will receive an intravenous injection of cRGD-ZW800-1 at least 2h
prior to surgery. Standard surgical procedure will be performed. After surgery,
FLI will be performed on the wound bed and
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients with biopsy-proven squamous cell LHC, eligible for surgical resection of the tumor by TL(P); - >= 18 years of age; - Written informed consent must be obtained; - Sufficient knowledge of the Dutch language to understand the informed consent form;
Exclusion criteria
Exclusion criteria: - History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent; - Other synchronous biopsy proven malignancies currently active, except for adequately treated in situ carcinomaof cervix and basal or squamous cell skin carcinoma; - Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductivepotential; - Patients with renal insufficiency (defined as eGFR<60); - Patients with previous kidney transplantation or a solitary functioning kidney - Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impairedor weakened immune system, caused by either a pre-existing disease or concomitant medications; - Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX-2inhibitors), that cannot be paused during the course of the study; - Patients with ASA classification of 4 or higher; - Patients with measured QTc of 500 ms or higher at screening; - Patients with laboratory abnormalities defined as: o Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or AlkalinePhosphatase levels above 5 times the ULN or; o Total bilirubin above 3 times the ULN or; o Platelet count below 100 x 109/L or; o Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males). - Incapacitated subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint of WP-1 is the tumor-to-background ratio (TBR) of laryngeal or pharyngeal tumours with fluorescence imaging after cRGD-ZW800-1 administration. The primary endpoint of WP-II is the number of clear resection margins. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sensitivity, specificity and positive predictive value of FLI; 2. The intraoperative change in surgical management based on FLI; 3. FLI of excised cervical lymph nodes; 4. Influence of previous radiotherapy on the FLI performance; 5. Adverse events and toxicity after intravenous injection with cRGD-ZW800-1; | — |
Countries
Netherlands
Outcome results
None listed