Axumin PET-CT for Brain Cancer

Overseen By Yang Lu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must be taking: Immunotherapy

Disqualifiers: Pregnancy, Severe allergies, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an 18F-Fluciclovine (Axumin) PET-CT scan can better detect brain tumors that have spread from other parts of the body in patients receiving immunotherapy. The goal is to determine if this scan provides clearer information than standard imaging tests. Individuals with brain tumors that may be worsening despite immunotherapy might be suitable for this study. Participants should be willing and able to undergo multiple scans and possibly a biopsy (a small tissue sample). As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future diagnostic techniques.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It mentions that you must be on active immunotherapy, and other treatments are allowed as determined by your doctor.

What prior data suggests that the Axumin PET-CT scan is safe for detecting brain metastatic lesions?

Research shows that 18F-Fluciclovine (Axumin) is generally safe and well-tolerated. Studies have found that this imaging agent performs well in PET scans and maintains a good safety record. Specifically, it is considered safe for detecting brain tumors, especially when other imaging methods might not be as effective. Although research on 18F-Fluciclovine continues to expand, current data does not reveal any major safety issues. Therefore, individuals considering participation in a trial with 18F-Fluciclovine can feel reasonably confident about its safety based on existing evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 18F-Fluciclovine (Axumin) for brain cancer because it offers a new way to visualize cancerous cells in the brain with a PET scan. Unlike traditional imaging techniques, this radiotracer is designed to highlight areas of increased amino acid transport, which is often heightened in cancer cells. This could potentially lead to more accurate detection and monitoring of brain tumors, helping doctors tailor treatment plans more effectively.

What evidence suggests that Axumin PET-CT scans are effective for detecting brain metastatic lesions?

Research has shown that 18F-Fluciclovine (Axumin) PET-CT scans, which participants in this trial will undergo, can help detect recurrent brain cancer. Studies have found that this scan can distinguish between actual tumor growth and changes that merely resemble growth after treatment. This capability is particularly useful for identifying brain tumors that return after radiation therapy. Clinical guidelines suggest that 18F-Fluciclovine PET-CT is valuable for diagnosing more aggressive cancer recurrences. Overall, early evidence supports its use as a promising tool for better understanding brain cancer progression. ^{1 5 6 7 8}

Who Is on the Research Team?

Yang Lu, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Adults over 18 with brain metastases from cancer, currently on immunotherapy, can join this trial. They must be able to consent, have a life expectancy of at least 3 months, and be willing to undergo additional scans or biopsies if needed. Pregnant or breastfeeding individuals, those with severe allergies to Axumin PET radiopharmaceuticals, or conditions affecting study compliance are excluded.

Inclusion Criteria

Willingness to participate in the study and ability to provide written informed consent.

You have been diagnosed with brain metastases, which are cancer that has spread to the brain.

Estimated life expectancy of at least 3 months as determined by the investigator or treating physician.

Exclusion Criteria

Patients with psychiatric illness/social situations that would limit compliance with study requirements.

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.

I have no severe allergies to Axumin PET scan dyes that can't be managed with medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1-2 visits (in-person)

Imaging

Participants undergo Axumin PET-CT scans to assess brain metastatic lesions

6-12 months

Up to 6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 18F-Fluciclovine (Axumin)
• PET Scan

Trial Overview The trial is testing whether a special type of PET-CT scan using a tracer called 18F-Fluciclovine (Axumin) is more effective in distinguishing between true progression and pseudo-progression of brain tumors in patients undergoing immunotherapy.

How Is the Trial Designed?

Group I: 18F-Fluciclovine (Axumin) Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Blue Earth Diagnostics

Industry Sponsor

Trials

43

Recruited

3,100+

Published Research Related to This Trial

The study involved 27 women with newly diagnosed locally advanced invasive ductal carcinoma (IDC) and invasive lobular carcinoma (ILC), and found that (18)F-fluciclovine PET/CT effectively visualized all cases of breast cancer, including detecting previously unsuspected extraaxillary nodal metastases in some patients.

While (18)F-fluciclovine showed strong concordance in measuring metabolic tumor volume compared to (18)F-FDG, the weak concordance for SUVmax indicates that these two imaging agents may reflect different biological processes in tumors, suggesting that (18)F-fluciclovine could provide unique insights into breast cancer biology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Results of a Prospective Clinical Trial of 18F-Fluciclovine PET/CT in Newly Diagnosed Invasive Ductal and Invasive Lobular Breast Cancers. Ulaner, GA., Goldman, DA., Gönen, M., et al.[2017]

In a phase IIa study involving 5 patients with malignant glioma, anti-[18F]FACBC demonstrated the ability to identify tumor regions that were not visible on conventional CE-T1W MRI, suggesting it may provide a more comprehensive assessment of glioma spread.

The safety profile of anti-[18F]FACBC was favorable, with only mild adverse events reported, indicating that it is a safe diagnostic tool for patients undergoing treatment for malignant glioma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase IIa clinical study of [18F]fluciclovine: efficacy and safety of a new PET tracer for brain tumors. Kondo, A., Ishii, H., Aoki, S., et al.[2017]

In a study involving 45 patients with suspected glioma, 18F-fluciclovine PET/CT demonstrated a high positive predictive value of 88.0% for identifying tumor areas that were not visible on traditional imaging, aiding in surgical planning.

The use of 18F-fluciclovine PET/CT led to modifications in the planned extent of tumor resection in nearly half of the cases, indicating its potential to improve surgical outcomes for glioma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining the extent of tumor resection at surgical planning with 18F-fluciclovine PET/CT in patients with suspected glioma: multicenter phase III trials. Wakabayashi, T., Hirose, Y., Miyake, K., et al.[2022]

The FDA recently approved F-labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC, F-fluciclovine) PET/CT scans for detecting suspected prostate cancer recurrence in men with elevated PSA levels after treatment.

In a unique case study of a 77-year-old man, the scan revealed not only suspected recurrent prostate cancer but also advanced-stage breast cancer, highlighting the potential for incidental findings during prostate imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metastatic Male Breast Cancer With Increased Uptake on 18F-Fluciclovine PET/CT Scan. Gill, HS., Tade, F., Greenwald, DT., et al.[2018]

18F-fluciclovine PET/CT is effective for detecting biochemically recurrent prostate cancer, but it can also reveal incidental findings, such as a pancreatic head mass.

In this case, the pancreatic mass appeared as a photopenic defect on the PET/CT scan and was later confirmed to be a benign serous cystadenoma through MRI, highlighting the importance of further investigation for unexpected findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidental Serous Cystadenoma Presenting as a Photopenic Pancreatic Defect on 18F-Fluciclovine PET/CT. Waltz, J., Mercer, MK., Dani, G., et al.[2023]

The 18 F-fluciclovine PET/CT scan effectively identified intense uptake in left adrenal gland metastasis in a prostate cancer patient, highlighting its utility in detecting visceral metastasis.

In contrast, the 18 F-NaF PET/CT scan showed intense uptake in multiple sclerotic bone metastases, indicating that both imaging techniques are necessary for a comprehensive evaluation of metastatic prostate cancer, as they provide complementary information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary Role of 18 F-Fluciclovine PET/CT and 18 F-NaF PET/CT in Detecting Prostate Cancer Metastasis. Xu, F., Liu, F., Chen, W.[2023]

The phase 1 trial involving six patients with prostate cancer demonstrated that [(18)F]fluciclovine is safe for human use, with no significant adverse events reported and minimal urine excretion of the tracer.

[(18)F]fluciclovine effectively visualized tumor deposits in prostate cancer, showing high uptake within the first 15 minutes post-injection, which suggests that early imaging provides the best results for assessing tumor metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional distribution and kinetics of [18F]fluciclovine (anti-[18F]FACBC), a tracer of amino acid transport, in subjects with primary prostate cancer. Sörensen, J., Owenius, R., Lax, M., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31418054/

18F-Fluciclovine (18F-FACBC) PET imaging of recurrent brain ... The aim of our study was to investigate the efficacy of 18 F-Fluciclovine brain PET imaging in recurrent gliomas, and to compare the utility of these images.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06015295

NCT06015295 | A Pilot Study to Assess the ... Primary Objective: To assess the diagnosis accuracy of 18F-Fluciclovine (Axumin) PET-CT in detecting true- versus pseudo-progression of brain metastatic lesions ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.2001

Evaluating the diagnostic performance of 18 F-fluciclovine ... Evaluating the diagnostic performance of 18F-fluciclovine for detection of recurrent brain metastases after radiation therapy: Results from a ...

4. link.springer.com link.springer.com/article/10.1007/s12149-025-02089-6

Clinical Practice Guidelines for 18F-Fluciclovine 2024 in ... From these findings, 18F-Fluciclovine PET appears potentially useful as an adjunct for the diagnosis of recurrence, especially in high-grade ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/jnumed/early/2022/12/22/jnumed.122.264812.full.pdf

18F-Fluciclovine PET in glioblastoma Phase iia clinical study of [(18)F]fluciclovine: Efficacy and safety of a new pet tracer for brain tumors. Ann Nucl Med. 2016;30:608-618. 18.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27418267/

efficacy and safety of a new PET tracer for brain tumors Objective: [18F]Fluciclovine (anti-[18F]FACBC) has demonstrated diagnostic efficacy for cancers of the brain where [18F]fludeoxyglucose has limitations. We ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05553041

18F-Fluciclovine PET-MRI in High-grade Glioma The purpose of this study is to see if 18F-fluciclovine (Axumin®) PET imaging is useful and safe in the management of children with High Grade Gliomas.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10742552/

Diagnostic Accuracy of PET with 18F-Fluciclovine ([18F ... Overall, literature data are still limited, but [18F]FACBC PET/CT or PET/MRI showed a good safety profile and good diagnostic accuracy for HGG ...