Brain MetastasesNCT06015295
A Pilot Study to Assess the Clinical Utility of 18F-Fluciclovine (Axumin) PET-CT for Detecting True-versus Pseudo-Progression of Brain Metastases on Immunotherapy
A study testing 18F-Fluciclovine (Axumin) and Pet Scan in people with Brain Metastases, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if 18F-Fluciclovine (Axumin) PET-CT scans can be used to better detect brain metastatic lesions in patients who are receiving immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- 18F-Fluciclovine (Axumin) and Pet Scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2024to 17 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
- ECOG performance status ≤2 (Karnofsky ≥60%,).
- Willingness to participate in the study and ability to provide written informed consent.
- Patients must have documented brain metastatic lesion(s) in the medical record.
- 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.
- 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).
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- 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.
- Ability and willingness to undergo another follow up Fluciclovine PET/CT, usually within 60 days of SoC follow up imaging modality.
- Ability and willingness to undergo biopsy if needed per standard of care.
- Estimated life expectancy of at least 3 months as determined by the investigator or treating physician.
Who cannot join
- 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.
- 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.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Unable to lie flat during or tolerate PET-CT
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To learn if 18F-Fluciclovine (Axumin) PET-CT scans can be used to better detect brain metastatic lesions in patients who are receiving immunotherapy.
Read the detailed description
Primary Objective:
- To assess the diagnosis accuracy of 18F-Fluciclovine (Axumin) PET-CT in detecting true- versus pseudo-progression of brain metastatic lesions in patients on immunotherapy.
Accuracy is defined as the number of concordant cases between Axumin PET-CT and the gold standard truth divided by the total sample size.
Secondary Objectives
- To assess diagnosis accuracy of Axumin PET-CT in detecting true- versus pseudo-progression of brain metastatic lesions in patients on immunotherapy by additional accuracy measures including sensitivity, specificity, negative predictive value and positive predictive value.
- To evaluate the added clinical usefulness of Axumin PET-CT for imaging patients with metastatic brain lesion(s).
- Conditions
- Brain Metastases
- Being tested
- 18F-Fluciclovine (Axumin), Pet Scan
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Fluciclovine (Axumin)Diagnostic test
Given by Injection
Pet ScanDiagnostic test
Scans
| Study group | Role | What they receive |
|---|---|---|
| 18F-Fluciclovine (Axumin) | Experimental | Participants are expected to be in this research study for about 6-12 months. Participants will have up to 6 visits for screening tests, Axumin PET-CT scans, and information collection. Receives: Diagnostic Test: 18F-Fluciclovine (Axumin); Diagnostic Test: Pet Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start7 Nov 2024
- Primary completion17 Sep 2026
- Study completion17 Sep 2026
Why it stopped: \<\&%% participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Sponsor
- Investigators
- Yang Lu, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015295
- Sponsor's protocol ID
- 2023-0159
- Other IDs
- NCI-2024-09643
- Status last verified
- Sep 2026
- First submitted
- 23 Aug 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Clinical Utility of 18F-Fluciclovine (Axumin) PET-CT for Detecting True-versus Pseudo-Progression of Brain Metastases on Immunotherapy
- ClinicalTrials.gov ID
- NCT06015295
- Acronym / sponsor ID
- 2023-0159
- Conditions
- Brain Metastases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \<\&%% participation
- Enrolment
- 3 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 17 Sep 2026 (actual)
- Study completion
- 17 Sep 2026 (actual)
- First posted
- 29 Aug 2023 (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.
To learn if 18F-Fluciclovine (Axumin) PET-CT scans can be used to better detect brain metastatic lesions in patients who are receiving immunotherapy.
Detailed description
Primary Objective:
- To assess the diagnosis accuracy of 18F-Fluciclovine (Axumin) PET-CT in detecting true- versus pseudo-progression of brain metastatic lesions in patients on immunotherapy.
Accuracy is defined as the number of concordant cases between Axumin PET-CT and the gold standard truth divided by the total sample size.
Secondary Objectives
- To assess diagnosis accuracy of Axumin PET-CT in detecting true- versus pseudo-progression of brain metastatic lesions in patients on immunotherapy by additional accuracy measures including sensitivity, specificity, negative predictive value and positive predictive value.
- To evaluate the added clinical usefulness of Axumin PET-CT for imaging patients with metastatic brain lesion(s).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-Fluciclovine (Axumin) | Experimental | Diagnostic Test: 18F-Fluciclovine (Axumin), Diagnostic Test: Pet ScanParticipants are expected to be in this research study for about 6-12 months. Participants will have up to 6 visits for screening tests, Axumin PET-CT scans, and information collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- ECOG performance status ≤2 (Karnofsky ≥60%,).
- Willingness to participate in the study and ability to provide written informed consent.
- Patients must have documented brain metastatic lesion(s) in the medical record.
- 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.
Key exclusion criteria (6 listed)
- 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.
- 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.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Unable to lie flat during or tolerate PET-CT
- 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.
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 |
|---|---|---|
| 18F-Fluciclovine (Axumin)Given by Injection | Diagnostic test | 18F-Fluciclovine (Axumin) |
| Pet ScanScans | Diagnostic test | 18F-Fluciclovine (Axumin) |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: through study completion; an average of 1 year
Results and safety
The study was stopped early (reason given: \<\&%% participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Yang Lu, MD 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 study testing 18F-Fluciclovine (Axumin) and Pet Scan in people with Brain Metastases, 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 10 inclusion and 6 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: stopped early, as of the sponsor's last update on 23 Sep 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.
Are results available for this study?
The study was stopped early (reason given: \<\&%% participation). Results are not available in the source record.
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?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average of 1 year). 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 23 Sep 2026.