Malignant Breast NeoplasmPhase 1NCT03168737
18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients
A Phase 1 study testing Computed Tomography, Fluorine F 18-fluoroazomycin Arabinoside and Positron Emission Tomography in people with Malignant Breast Neoplasm and Malignant Colorectal Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Breast Neoplasm, Malignant Colorectal Neoplasm, Malignant Pancreatic Neoplasm
- What is being tested?
- Computed Tomography, Fluorine F 18-fluoroazomycin Arabinoside and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2017to 30 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Test-Retest of (18)F-Fluoroazomycin Arabinoside ([18F]FAZA) PET-CT of Solid Tumors
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Malignant Breast Neoplasm, Malignant Colorectal Neoplasm, Malignant Pancreatic Neoplasm, Malignant Solid Neoplasm
- Being tested
- Computed Tomography, Fluorine F 18-fluoroazomycin Arabinoside, Positron Emission Tomography
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography
Undergo PET-CT scan
Fluorine F 18-fluoroazomycin ArabinosideRadiation
Also called 18F-FAZA, 18F-Fluoroazomycin Arabinoside, FAZA F-18, FLUOROAZOMYCIN ARABINOSIDE F-18
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET-CT scan
| Study group | Role | What they receive |
|---|---|---|
| Group A (18F-fluoroazomycin arabinoside, PET-CT scans) | Experimental | 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. Receives: Procedure: Computed Tomography; Radiation: Fluorine F 18-fluoroazomycin Arabinoside; Procedure: Positron Emission Tomography |
| Group B (18F-fluoroazomycin arabinoside, PET-CT scans) | Experimental | 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. Receives: Procedure: Computed Tomography; Radiation: Fluorine F 18-fluoroazomycin Arabinoside; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start22 Sep 2017
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Franklin C Wong, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168737
- Sponsor's protocol ID
- 2016-0847
- Other IDs
- NCI-2018-01196, 2016-0847
- Status last verified
- Oct 2026
- First submitted
- 24 May 2017
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-Retest of (18)F-Fluoroazomycin Arabinoside ([18F]FAZA) PET-CT of Solid Tumors
- ClinicalTrials.gov ID
- NCT03168737
- Acronym / sponsor ID
- 2016-0847
- Conditions
- Malignant Breast Neoplasm, Malignant Colorectal Neoplasm, Malignant Pancreatic Neoplasm, Malignant Solid Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (18F-fluoroazomycin arabinoside, PET-CT scans) | Experimental | Procedure: Computed Tomography, Radiation: Fluorine F 18-fluoroazomycin Arabinoside, Procedure: Positron Emission TomographyPatients 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) | Experimental | Procedure: Computed Tomography, Radiation: Fluorine F 18-fluoroazomycin Arabinoside, Procedure: Positron Emission TomographyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, computerized tomographyUndergo PET-CT scan | Procedure or surgery | Group A (18F-fluoroazomycin arabinoside, PET-CT scans), Group B (18F-fluoroazomycin arabinoside, PET-CT scans) |
| Fluorine F 18-fluoroazomycin ArabinosideAlso: 18F-FAZA, 18F-Fluoroazomycin Arabinoside, FAZA F-18, FLUOROAZOMYCIN ARABINOSIDE F-18Given IV | Radiation | Group A (18F-fluoroazomycin arabinoside, PET-CT scans), Group B (18F-fluoroazomycin arabinoside, PET-CT scans) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET-CT scan | Procedure or surgery | Group A (18F-fluoroazomycin arabinoside, PET-CT scans), Group B (18F-fluoroazomycin arabinoside, PET-CT scans) |
Primary outcome
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])
Time frame: Baseline up to 30 days
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.
Incidence of adverse events per Common Terminology Criteria for Adverse Events version 4.03
Time frame: Up to 30 days
Adverse events and vital signs will be monitored and described with descriptive statistics.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Malignant Breast Neoplasm
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 1
A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
Non Small Cell Lung Cancer, Triple Negative Breast Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franklin C Wong principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Computed Tomography, Fluorine F 18-fluoroazomycin Arabinoside and Positron Emission Tomography in people with Malignant Breast Neoplasm and Malignant Colorectal Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]) (time frame: Baseline up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026; AzTrials last refreshed its copy on 4 Nov 2026.