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

Primary Purpose

Tongue Cancer

Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
(18)F-Fluoroazomycin arabinoside
Pimonidazole
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tongue Cancer focused on measuring Oral Tongue Cancer, Tumor Hypoxia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Odette Cancer Centre, Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FAZA and pimonidazole

Arm 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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Registration quality
The quality of registration will be assessed through measuring registration error of various automatic and semi-automatic co-registration techniques
Textural feature comparison
Potential relationships between textural features of MRI, PET-CT, and immunohistochemistry will be evaluated.

Full Information

First Posted
April 17, 2017
Last Updated
December 19, 2022
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Sunnybrook Research Institute, University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03181035
Brief Title
Correlation of FAZA PET Hypoxia Imaging To 3D Histology in Oral Tongue Cancer
Acronym
FAITH
Official Title
Defining a Personalized Hypoxic Radiation Target Through Correlation of Functional F18-FAZA PET Imaging to Pimonidazole-stained 3D Whole-mounted Histological Specimen
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Sunnybrook Research Institute, University of Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In head and neck cancer, areas of tumours with low oxygen supply (called tumour hypoxia) harbour cells that are resistant to radiation and are prone to metastasize. Modern radiotherapy techniques are precise enough to deliver radiation to these small areas and could be used to target these areas to receive higher doses of radiation than the rest of the tumour to overcome resistance. Hypoxia can be "seen" in the body using special imaging such as [F-18]-FAZA-PET ([F-18]-Fluoroazomycin arabinoside positron emission tomography) but it has not been tested as a method for creating radiation treatment targets. As part of regular pathology tumour tissue is sliced extremely thinly (<1/100th of a millimeter) and stained so that individual cells can be seen under a microscope. Immunohistochemistry (IHC) is a special type of "stain" that can specifically highlight hypoxic areas. This method is considered the most accurate way to inspect for the presence of hypoxia. There is not a specific staining target for hypoxia ordinarily, but when patients ingest a substance called pimonidazole hydrochloride (HCl) it builds up specifically in hypoxic areas and can be targeted for IHC staining. In this study participants with oral tongue cancer will have a [F-18]-FAZA-PET scan and take a single dose of oral pimonidazole-HCl before having surgery to remove their cancer. The whole tumour will be used to create microscope slides using very thin slices of the tumour. The slices will be stained using IHC to show where the pimonidazole has built up and digital scans of the slides will be made. The hypoxia seen on the FAZA-PET scan will be "matched" with hypoxia on the electronic slides to see if the FAZA truly shows where hypoxia is in tumours and if it could be used as a way to plan radiation treatments to deliver more radiation to just those areas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tongue Cancer
Keywords
Oral Tongue Cancer, Tumor Hypoxia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FAZA and pimonidazole
Arm Type
Experimental
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
(18)F-Fluoroazomycin arabinoside
Other Intervention Name(s)
FAZA
Intervention Description
FAZA PET diagnostic testing
Intervention Type
Drug
Intervention Name(s)
Pimonidazole
Intervention Description
oral pimonidazole hypoxia labeling
Primary Outcome Measure Information:
Title
Cellular hypoxia correlation
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
Time Frame
1 year
Title
Hypoxic reference standard
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Registration quality
Description
The quality of registration will be assessed through measuring registration error of various automatic and semi-automatic co-registration techniques
Time Frame
1 year
Title
Textural feature comparison
Description
Potential relationships between textural features of MRI, PET-CT, and immunohistochemistry will be evaluated.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ian Poon, MD, FRCPC
Phone
416-480-6100
Ext
4951
Email
ian.poon@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Poon, MD, FRCPC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odette Cancer Centre, Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Poon, MD, FRCPC
Phone
416-480-6100
Ext
4951
Email
ian.poon@sunnybrook.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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