18F-Fluoroazomycin Arabinoside PET-CT In Diagnosing Solid Tumors In Patients

Study Overview

18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients

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.

PRIMARY OBJECTIVES: 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.

Malignant Breast Neoplasm
Malignant Colorectal Neoplasm
Malignant Pancreatic Neoplasm
Malignant Solid Neoplasm

PROCEDURE: Computed Tomography
RADIATION: Fluorine F 18-fluoroazomycin Arabinoside
PROCEDURE: Positron Emission Tomography

2016-0847
NCI-2018-01196 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))
2016-0847 (OTHER Identifier) (OTHER: M D Anderson Cancer Center)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-05-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-28
First Submitted that Met QC Criteria 2017-05-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-01
First Posted (ACTUAL) 2017-05-30	Results First Posted N/A	Last Verified 2025-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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.	PROCEDURE: Computed Tomography Undergo PET-CT scan RADIATION: Fluorine F 18-fluoroazomycin Arabinoside Given IV PROCEDURE: Positron Emission Tomography Undergo PET-CT scan
EXPERIMENTAL: 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.	PROCEDURE: Computed Tomography Undergo PET-CT scan RADIATION: Fluorine F 18-fluoroazomycin Arabinoside Given IV PROCEDURE: Positron Emission Tomography Undergo PET-CT scan

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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.

PROCEDURE: Computed Tomography

Undergo PET-CT scan

RADIATION: Fluorine F 18-fluoroazomycin Arabinoside

Given IV

PROCEDURE: Positron Emission Tomography

Undergo PET-CT scan

EXPERIMENTAL: 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.

PROCEDURE: Computed Tomography

Undergo PET-CT scan

RADIATION: Fluorine F 18-fluoroazomycin Arabinoside

Given IV

PROCEDURE: Positron Emission Tomography

Undergo PET-CT scan

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Franklin C Wong, M.D. Anderson Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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