Overview

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:
Cancer Care Ontario
Princess Margaret Hospital, Canada
Sunnybrook Research Institute
University of Toronto
University of Western Ontario, Canada
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