Correlation of FAZA PET Hypoxia Imaging To 3D Histology in Oral Tongue Cancer

• Status: Recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study in the form of a prospective Phase II, single centre, single arm hypoxia study of oral tongue cancer with FAZA-PET imaging and pimonidazole targeted IHC of surgical specimens.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Sunnybrook Research Institute; University of Toronto
• Treatments: Fluoroazomycin arabinoside

Criteria

Inclusion Criteria:

• Biopsy proven Stage II-III oral tongue squamous cell carcinoma

• Naïve to treatment for resectable disease

• Surgical resection as definitive treatment modality

• Ability to participate and willingness to give written informed consent prior to performance of any study-related procedures and to comply with the study protocol

• Adequate hematologic, renal and liver function as defined by the following laboratory values up to 30 days prior to commencement of dosing (administration of FAZA):

• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

• Platelet count ≥ 50 ×109/L

• Hemoglobin ≥ 9 g/dL

• Bilirubin ≤ 1.5 × upper limit of normal (ULN) (20.0 µmol)

• Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 × the ULN (37 U/L, 40 U/L, 120 U/L)

• Serum creatinine ≤ 1.5 × the ULN (106 µmol/L) or creatinine clearance ≥ 50 mL/min on the basis of the Cockroft-Gault glomerular filtration rate estimation: [(140-age) × (weight in kg × (0.85 if female)]/[72 × (serum creatinine in mg/dL)]

• Prothrombin time (PT), international normalized ratio (INR), partial thromboblastin time (PTT) ≤ 1.5 × the ULN (respectively 1.1, 14 sec, 35 sec)

• Negative serum pregnancy test within 14 days prior to commencement of dosing in women of childbearing potential. Women of non-childbearing potential need not undergo pregnancy testing. Female participants of childbearing potential agree to use adequate methods of contraception from the time of enrollment until 28 days after surgery. Clinically acceptable methods of birth control for this study include intrauterine devices (IUD), birth control pills, hormonal implants, injectable contraceptives, and using barrier methods such as condoms, vaginal diaphragm with spermicide, or sponge.

Exclusion Criteria:

• Patients who have received prior chemotherapy or radiation therapy for their oral tongue carcinoma

• Stage I, Stage III T1/N1/M0, and Stage IV disease

• Pregnant or breastfeeding at the time of consent