18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients
NCT ID: NCT03168737
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1
25 participants
INTERVENTIONAL
2017-09-22
2027-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTF
NCT03604315
18-F-Fluoroacetate as PET Imaging Agent
NCT01320787
18F-FMAU PET/CT in Imaging Patients With Advanced Cancers
NCT02079181
Positron Emission Tomography Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation
NCT00894101
FLT-PET in Predicting Response to Chemotherapy in Patients With Advanced Malignancies
NCT00880074
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To evaluate the feasibility of PET-CT using 18F-fluoroazomycin arabinoside (\[18F\]FAZA) and to determine the optimal imaging time to detect hypoxia in solid tumors.
SECONDARY OBJECTIVES:
I. To determine the variability of imaging findings from repeated \[18F\]FAZA PET-CT studies over \>= 24 hours up to 10 days.
II. To confirm the safety of \[18F\]FAZA administered during PET-CT imaging of hypoxia of solid tumors.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP A: Patients receive 18F-fluoroazomycin arabinoside intravenously (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: 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.
After completion of study treatment, patients are followed up at 24 hours and at 30 days.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A (18F-fluoroazomycin arabinoside, PET-CT scans)
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.
Computed Tomography
Undergo PET-CT scan
Fluorine F 18-fluoroazomycin Arabinoside
Given IV
Positron Emission Tomography
Undergo PET-CT scan
Group B (18F-fluoroazomycin arabinoside, PET-CT scans)
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.
Computed Tomography
Undergo PET-CT scan
Fluorine F 18-fluoroazomycin Arabinoside
Given IV
Positron Emission Tomography
Undergo PET-CT scan
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Computed Tomography
Undergo PET-CT scan
Fluorine F 18-fluoroazomycin Arabinoside
Given IV
Positron Emission Tomography
Undergo PET-CT scan
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Franklin C Wong
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
M D Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
University of Texas MD Anderson Cancer Center Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2018-01196
Identifier Type: REGISTRY
Identifier Source: secondary_id
2016-0847
Identifier Type: OTHER
Identifier Source: secondary_id
2016-0847
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.