New scan could reveal tumor oxygen levels, guiding better cancer treatment
NCT ID NCT03168737
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This early-phase study tests how well a special PET-CT scan called FAZA can measure oxygen levels in solid tumors like breast, colorectal, and pancreatic cancers. About 25 participants will receive the FAZA tracer and undergo imaging to see if the results are consistent over time. The goal is to help doctors plan more effective treatments by understanding tumor oxygen levels.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2017
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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