New scan may spot fake tumor growth in brain cancer patients
NCT ID NCT06015295
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This small pilot study tests whether a special PET scan called Axumin can help doctors tell the difference between real tumor growth and treatment-related inflammation (pseudo-progression) in people with brain metastases who are on immunotherapy. The study enrolled 3 adults with brain metastases. The goal is to improve detection accuracy and avoid unnecessary treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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3 people
The number who actually took part.
- Started
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Nov 2024
- Expected to finish
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Mar 2028
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: 1. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of Axumin in pediatric patients, patients \<18 years of age are excluded from this study. 2. ECOG performance status ≤2 (Karnofsky ≥60%,). 3. Willingness to participate in the study and ability to provide written informed consent. 4. Patients must have documented brain metastatic lesion(s) in the medical record. 5. On active immunotherapy for the diagnosed malignancy. Concurrent other treatment is allowed. Immunotherapy and other treatment regimens are determined by treating physicians as per standard clinical practice. 6. Patients with at least one metastatic brain lesion showing suspected pseudoprogression on SoC imaging modality (such as CT, or MRI, or FDG PET-CT, or DOTATATE PET/CT, or PSMA PET/CT). 7. The suspected pseudoprogresson can be determined by imaging physician (such as neuroradiologists and/or nuclear medicine physicians) and/or treating physicians (usually are oncologists). Ideally, the target/index lesion should be measurable (at discretion of investigator imaging physicians) and feasible for series follow up and comparison at imaging physician's discretion. 8. Ability and willingness to undergo another follow up Fluciclovine PET/CT, usually within 60 days of SoC follow up imaging modality. 9. Ability and willingness to undergo biopsy if needed per standard of care. 10. Estimated life expectancy of at least 3 months as determined by the investigator or treating physician. Exclusion Criteria: 1. Pregnant or breastfeeding during participation in the study are excluded because: There is no information on the risk of adverse developmental outcomes in pregnant women or animals with the use of Fluciclovine F18. All radiopharmaceuticals, including Axumin, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose; There is no information on the presence of Fluciclovine F18 in human milk, the effect on the breastfed infant, or the effect on milk production. 2. History of severe allergic reactions to Axumin PET radiopharmaceuticals. Mild to moderate reactions that can be controlled by medications prior to the scheduled PET/CT are acceptable. 3. Patients with psychiatric illness/social situations that would limit compliance with study requirements. 4. Unable to lie flat during or tolerate PET-CT 5. Contraindications to Axumin Injection have not been established in humans. None are known or have been observed in nonclinical or clinical studies performed to date. 6. Subjects with any medical condition or circumstance that the investigator believes may compromise the safety or compliance of the subject to produce reliable data or completing the study.
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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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