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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

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

NCT ID

NCT03181035

First Posted

April 17, 2017

Last Updated

December 19, 2022

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Sunnybrook Research Institute, University of Toronto

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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

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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