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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My tumor is at least 1 cm wide, confirmed by imaging tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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])
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
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240
Fluorine F 18-fluoroazomycin Arabinoside
2020
N/A
~30
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,756 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,128 Total Patients Enrolled
Franklin C WongPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor is at least 1 cm wide, confirmed by imaging tests.I, or my legal representative if I'm unable, understand and agree to participate in the study.If you weigh 400 pounds or more, or if your body size would affect the quality of the imaging tests, you cannot participate.I haven't had any cancer treatment in the last month.I am not allergic to [18F] FAZA.I am not scheduled for cancer treatment before my imaging sessions are done.If you are breastfeeding, you need to stop for at least two days after getting the [18F] FAZA injection because it might not be safe for your baby.I have a solid tumor diagnosis, with priority if it's in the breast, pancreas, or colon.
Research Study Groups:
This trial has the following groups:- Group 1: Group A (18F-fluoroazomycin arabinoside, PET-CT scans)
- Group 2: Group B (18F-fluoroazomycin arabinoside, PET-CT scans)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How much of a hazard does Fluorine F 18-fluoroazomycin Arabinoside pose to individuals?
"Our team at Power has assessed the safety of Fluorine F 18-fluoroazomycin Arabinoside to be a 1 due to its Phase 1 categorization, which signifies that there is limited evidence for both efficacy and safety."
Answered by AI
Does this research still have room to enroll new participants?
"According to the details hosted on clinicaltrials.gov, this trial is not enrolling new patients at present. Initially posted in September 2017 and last updated in August 2022, it has yet to reach its recruitment target of 5768 participants."
Answered by AI
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