18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients
Test-Retest of (18)F-Fluoroazomycin Arabinoside ([18F]FAZA) PET-CT of Solid Tumors
2 other identifiers
interventional
25
1 country
1
Brief Summary
This early phase I trial studies how well 18F-fluoroazomycin arabinoside positron emission tomography (PET)-computed tomography (CT) works in diagnosing solid tumors. Using 18F-fluoroazomycin arabinoside with PET-CT may help doctors plan better treatment for patients with solid tumors. 18F-fluoroazomycin arabinoside may help to show how much oxygen is present in a tumor during a PET-CT scan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2017
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2017
CompletedFirst Posted
Study publicly available on registry
May 30, 2017
CompletedStudy Start
First participant enrolled
September 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
April 15, 2026
April 1, 2026
9.6 years
May 24, 2017
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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])
Summary statistics of tumor volume, SUV, TMR, HTV1, HTV2, TLH1, TLH2, and their changes from baseline to later time point will be provided in mean, standard deviation, and range by time point. Lin's concordance correlation coefficient for these parameters will be calculated and MDC95 will also be calculated for 2 hour timepoint or other time points. Other statistical analyses will be carried out as appropriate.
Baseline up to 30 days
Incidence of adverse events per Common Terminology Criteria for Adverse Events version 4.03
Adverse events and vital signs will be monitored and described with descriptive statistics.
Up to 30 days
Study Arms (2)
Group A (18F-fluoroazomycin arabinoside, PET-CT scans)
EXPERIMENTALPatients 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.
Group B (18F-fluoroazomycin arabinoside, PET-CT scans)
EXPERIMENTALPatients 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.
Interventions
Undergo PET-CT scan
Given IV
Undergo PET-CT scan
Eligibility Criteria
You may qualify if:
- Patients with histopathologic diagnosis of a solid tumor. All solid tumors will be considered, but patients with breast, pancreas, and colorectal masses will be prioritized.
- 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.
- A patient who has not received systemic or loco-regional treatment of the tumor within the last month.
- Ability of the subject, or the legally authorized representative (LAR) if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, to understand, and the willingness to sign, a written informed consent.
- Patients who are not expected to receive cancer therapy before imaging sessions are completed.
You may not qualify if:
- Pregnant or lactating women: pregnant women are excluded from this study because the effects of \[18F\] FAZA in pregnancy are not known. A urine or serum pregnancy test will be performed before accrual after informed consent is obtained.
- Lactation should be suspended for at least two days following the administration of \[18F\] FAZA to the mother, because of the unknown but potential risk for adverse events in nursing infants secondary to administration of the radionuclide to a lactating woman.
- Subjects with contraindications to the use of \[18F\] FAZA including confirmed allergy.
- Patients with a body weight of 400 pounds or more, or a body mass index (BMI) which precludes their entry into the bore of the PET/CT scanner, because the findings will probably be compromised in image quality with CT, PET/CT and MRI.
- Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Franklin C Wong
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2017
First Posted
May 30, 2017
Study Start
September 22, 2017
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
April 15, 2026
Record last verified: 2026-04