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Hypoxia Imaging Agent

FAZA PET Imaging for Tongue Cancer (FAITH Trial)

Phase 1 & 2

Recruiting

Led By Ian Poon, MD, FRCPC

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Naïve to treatment for resectable disease

Surgical resection as definitive treatment modality

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

FAITH Trial Summary

This trial is testing a new way to image and treat oral tongue cancer.

Who is the study for?

This trial is for adults with Stage II-III oral tongue squamous cell carcinoma who haven't had previous treatments and are scheduled for surgical removal of the cancer. They must have proper liver, kidney, and blood function, not be pregnant or breastfeeding, and willing to use contraception.Check my eligibility

What is being tested?

The study tests how well a PET scan using a tracer called FAZA can show low oxygen areas in tongue tumors compared to standard tissue staining with pimonidazole after surgery. It's a Phase II trial where all participants receive the same imaging and treatment.See study design

What are the potential side effects?

Potential side effects aren't specified but may include reactions related to PET imaging such as discomfort at injection site or allergic reaction to tracers. Surgical risks apply based on individual health status.

FAITH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not received any treatment for my operable disease.

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I had surgery as my main cancer treatment.

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My kidney function is within the required range.

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My biopsy shows I have Stage II-III cancer of the tongue.

FAITH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cellular hypoxia correlation

Hypoxic reference standard

Secondary outcome measures

Registration quality

Textural feature comparison

FAITH Trial Design

1Treatment groups

Experimental Treatment

Group I: FAZA and pimonidazoleExperimental Treatment2 Interventions

(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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pimonidazole

Not yet FDA approved

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Research InstituteOTHER

31 Previous Clinical Trials

215,809 Total Patients Enrolled

University of TorontoOTHER

690 Previous Clinical Trials

1,019,633 Total Patients Enrolled

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,298 Total Patients Enrolled

Media Library

FAZA PET (Hypoxia Imaging Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03181035 — Phase 1 & 2

Tongue Cancer Research Study Groups: FAZA and pimonidazole

Tongue Cancer Clinical Trial 2023: FAZA PET Highlights & Side Effects. Trial Name: NCT03181035 — Phase 1 & 2

FAZA PET (Hypoxia Imaging Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03181035 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the recruitment rate for this trial?

"Affirmative. According to the records on clinicaltrials.gov, this investigation is actively looking for participants and was first published on January 25th 2018 with its most recent update occurring October 20th 2021. This study requires 10 people from one site to participate."

Answered by AI

Are enrollments still open for the current trial?

"The trial, which was first advertised on the 25th of January 2018, is still actively recruiting patients. The most recent update to its listing was made on October 20th 2021."

Answered by AI

Are there any existing investigations of (18)F-Fluoroazomycin arabinoside?

"Presently, two medical studies are underway for (18)F-Fluoroazomycin arabinoside - both of which are currently in Phase 2. Most research is centered around Toronto, Ontario; however there are a couple of other trial sites spread across the country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Correlation of FAZA PET Hypoxia Imaging To 3D Histology in Oral Tongue Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03181035.