Oral and oropharyngeal squamous cell carcinoma MedDRA version: 21.0 Level: PT Classification code 10041857 Term: Squamous cell carcinoma of the oral cavity System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10031112 Term: Oropharyngeal squamous cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
FluoGuide A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Naive subjects with primary biopsy-proven squamous cell carcinoma (with or without metastaseis) of the oral cavity or oropharynx eligible for resection of the primary tumor at the trial site 2. The subjects can be scheduled for sentinel node biopsy (SNB) without ICG 3. Subjects with a sub side oral or oropharyngeal cancer i.e., cancer re occurrence is in a new area 4. Location of tumor suitable for imaging i.e., isolated/detached cancer where the subject can open the mouth for the tumor to be accessible 5. Subjects aged 18 years or older 6. Capable of understanding and giving written informed consent 7. Subject must not previously have received the trial drug (FG001) 8. Male subjects must commit to use barrier contraception (e.g., condom) during the trial and for 30 days after the end-of-trial visit and avoid sperm donation during this period 9. Women of childbearing potential must agree to use an adequate method of contraception during the trial and for 30 days after the end-of-trial visit. Adequate methods of contraception include intrauterine device or hormonal contraception (oral contraceptive pill, depot injections or implant, transdermal depot patch or vaginal ring). To be considered sterilised or infertile, females must have undergone surgical sterilisation (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhoea; may be confirmed with follicle-stimulating hormone [FSH] test if there is doubt) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: 1. Scheduled sentinel node biopsy (SNB) with ICG-based optical tracer 2. Previous surgery, chemotherapy or radiotherapy to the oral cavity 3. Any known allergy or hypersensitivity to indocyanine green (ICG) or any other component of the drug product 4. Female subjects who are pregnant or breast-feeding (pregnancy test positive prior to inclusion) 5. Overall performance status or co-morbidity deeming the subject unfitted for participation in the trial as judged by the Investigator 6. Pre-existing hepatic and/or renal insufficiency o Estimated GFR (eGFR) 1.7 If a subject is being treated with anticoagulants and the INR is borderline (1.8) and the PI judges the subject to be eligible with no safety concerns AND the CMO at FluoGuide agrees, such subject may be deemed eligible for the trial. This must be clearly documented in the medical journal and at FluoGuide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate FG001 for the detection of oral and oropharyngeal cancer;Secondary Objective: • To evaluate the pharmacokinetics profile (PK) of single i.v dose of FG001 • To evaluate safety and tolerability of FG001 ;Primary end point(s): • Sensitivity for detection of oral and oropharyngeal cancer verified by histology ;Timepoint(s) of evaluation of this end point: The efficacy of FG001 (as a tumor imaging agent) is examined by the sensitivity, which is verified via the intensity of fluorescence from the specimen taken post-surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a. Efficacy 1. Tumor To Background Ratio, TBR: Signal intensity in tumor 2. PK profile determined by non-compartmental analysis: • Peak plasma concentration (Cmax) • Time of peak plasme concentration (tmax) • Area under the plasma concentration-time curve from time-zero extrapolated to infinity (AUC0-inf) • Area under the plasma concentration-time curve from time-zero to last quantifiable concentration (AUC0-t) • Terminal half-life (t½) b. Safety and tolerability • Adverse Events • Laboratory parameters • 12 - lead ECG parameters • Vital Signs ;Timepoint(s) of evaluation of this end point: TBR will be calculated as the fluorescence of the tumor relative to background tissue, as measured by near-infrared (NIR) imaging. This is imaged in situ during resection The PK profile will be determined for all included subjects undergoing surgery by obtaining 5 PK samples per subject during the trial, with first measurement at hour 1± 15 minutes post-injection and last at Hour 44 1± 6h (EoT) Safety and Tolerability will be evaluated from Baseline visit (Pre-surgery) until the EoT. | — |
Countries
Denmark
Contacts
Public ContactRegulatory Affairs
Ozack ApS
Outcome results
None listed