Clinical trial · Interventional
Correlation of FAZA PET Hypoxia Imaging To 3D Histology in Oral Tongue Cancer
Defining a Personalized Hypoxic Radiation Target Through Correlation of Functional F18-FAZA PET Imaging to Pimonidazole-stained 3D Whole-mounted Histological Specimen
NCT03181035CI-TRIAL-00079726FAITHsuspendedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Pause to enrolment due to COVID-19 pandemic and protocol amendment (change to equipment used)
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tongue Cancer | Malignant Tongue Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| (18)F-Fluoroazomycin arabinoside | Radiation | — | UNRESOLVED |
| Pimonidazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FAZA and pimonidazole
- description
- (18)F-Fluoroazomycin arabinoside (FAZA) will be administered via intravenous injection at a dose of 5.2 MBq/kg with a minimum dose of 200 Megabecquerel (MBq) (5.4 Millicurie (mCi)) and a maximum dose of 600 MBq (16.2 mCi) prior to positron emission tomography (PET) imaging. A single dose of oral pimonidazole capsules at a dose of 0.5 g/m2, will be taken by participants 16-20 hours prior to tumor resection surgery.
- interventionNames
- Radiation: (18)F-Fluoroazomycin arabinoside
- Drug: Pimonidazole
Primary outcomes (2)
- measure
- Cellular hypoxia correlation
- timeFrame
- 1 year
- description
- The degree to which hypoxic signal measured by FAZA-PET imaging is correlated with true cellular hypoxia confirmed by immunohistochemical staining of pimonidazole using a 3D whole-mount approach
- measure
- Hypoxic reference standard
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.