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

NCT03181035 | Suspended Phase 1

• 1 other identifier: FAITH 253-2015
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tongue Cancer

Keywords

Oral Tongue Cancer; Tumor Hypoxia

Outcome Measures

Primary Outcomes (2)

• Cellular hypoxia correlation

  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

  1 year

• Hypoxic reference standard

  A reference standard hypoxic radiation target will be defined through the correlation of functional F18-FAZA PET imaging to a pimonidazole-stained 3D whole mounted histological specimen.

  1 year

Secondary Outcomes (2)

• Registration quality

  1 year

• Textural feature comparison

  1 year

Study Arms (1)

FAZA and pimonidazole

EXPERIMENTAL

(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.

Radiation: (18)F-Fluoroazomycin arabinoside; Drug: Pimonidazole

Interventions

(18)F-Fluoroazomycin arabinoside RADIATION

FAZA PET diagnostic testing

Also known as: FAZA

FAZA and pimonidazole

Pimonidazole DRUG

oral pimonidazole hypoxia labeling

FAZA and pimonidazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Sunnybrook Research Institute: collaborator
• University of Toronto: collaborator

Study Sites (1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Tongue Neoplasms

Interventions

pimonidazole

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Study Officials

• Ian Poon, MD, FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: June 8, 2017
• Study Start: January 25, 2018
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-07

Locations

CA (1)