E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Squamous Cell Carcinoma of the Oral Cavity |
plaveiselcelcarcinoom in de mond |
|
E.1.1.1 | Medical condition in easily understood language |
cancer of the oral cavity |
mondkanker |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To improve adequate resection of oral cancer using fluorescent imaging technology: 1. To determine the recommended dose for the highest tumor-to-background ratio (TBR) of at least >2.0 using cRGD-ZW800-1 in oral cancer; 2. To increase the rate of adequate (i.e. >5mm clear) tumor resection margins |
|
E.2.2 | Secondary objectives of the trial |
1. To determine the recommended dosage of cRGD-ZW800-1 for intraoperative imaging of oral cancer. 2. To determine the sensitivity, specificity, positive and negative predictive values of FLI 3. To-determine colocalization of FLI with immunochemistry on pathology slides 4. To determine the percentage of extra tissue resection based on FLI-driven frozen sections 5. To determine if FLI significantly increases operation time 6. To determine if lymph node metastases can be identified using FLI |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor; 2. Patients ≥ 18 years of age; 3. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. |
|
E.4 | Principal 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. Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX-2 inhibitors); 7. 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; 8. Any condition that the investigator, anesthesiologist or head- and neck surgeon considers to be potentially jeopardizing the patient’s well-being or the study objectives.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Rate of adequate (i.e. >5mm clear) tumor resection margins. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
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 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |