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18F-AZA PET-CT Imaging for Cancer Diagnosis

Phase 1

Waitlist Available

Led By Franklin C Wong

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patient must have a solid tumor with a short-axis greater than or equal to 1 cm (by CT, magnetic resonance imaging [MRI], ultrasonography or mammography) to allow reliable PET imaging.

Be older than 18 years old

Must not have

Subjects with contraindications to the use of [18F] FAZA including confirmed allergy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a new imaging technique to study how well it works in diagnosing solid tumors. This technique may help doctors plan better treatment for patients with solid tumors.

Who is the study for?

This trial is for patients with solid tumors, especially those with breast, pancreatic, or colorectal cancer. Participants must not have had recent treatment for their tumor and should have a mass at least 1 cm in size. They need to understand and sign consent forms (or have a legal representative do so if necessary) and can't start other cancer treatments during the study. Pregnant women, individuals allergic to [18F] FAZA, those over 400 pounds or with high BMI that affects imaging quality are excluded.

What is being tested?

The trial is testing how well an imaging compound called 18F-fluoroazomycin arabinoside works when used in PET-CT scans for diagnosing solid tumors. The goal is to see if this method can better indicate the oxygen levels in tumors which may help plan more effective treatments.

What are the potential side effects?

Since this trial involves diagnostic imaging rather than drug treatment, side effects are minimal but may include reactions related to allergy to [18F] FAZA or discomfort from lying still during the PET-CT scan.

Eligibility Criteria

Inclusion Criteria

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

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My tumor is at least 1 cm wide, confirmed by imaging tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not allergic to [18F] FAZA.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events per Common Terminology Criteria for Adverse Events version 4.03

Relative change of imaging parameters (tumor volume, standardized uptake value [SUV], tumor to muscle ratio [TMR], hypoxic tumor volume [HTV1, HTV2], and total lesion hypoxia [TLH1, TLH2])

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group B (18F-fluoroazomycin arabinoside, PET-CT scans)Experimental Treatment3 Interventions

Patients receive 18F-fluoroazomycin arabinoside IV and after 60 minutes undergo 5 or less PET-CT scans on day 1 and 5 or less PET-CT scans \>= 24 hours later up to 10 days.

Group II: Group A (18F-fluoroazomycin arabinoside, PET-CT scans)Experimental Treatment3 Interventions

Patients receive 18F-fluoroazomycin arabinoside IV and after 60 minutes undergo 5 PET-CT scans at 60, 90, 120, 150, and 180 minutes on days 1 and 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Positron Emission Tomography

2011