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

Trial Summary

What is the purpose of this trial?

To learn if 18F-Fluciclovine (Axumin) PET-CT scans can be used to better detect brain metastatic lesions in patients who are receiving immunotherapy.

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 data supports the effectiveness of the drug Axumin PET-CT for brain cancer?

Research shows that [18F]Fluciclovine (Axumin) has been effective in diagnosing brain tumors, especially where other methods have limitations. It has also been used successfully in detecting prostate and breast cancers, indicating its potential usefulness in identifying various types of cancer. ^{1 2 3 4 5}

Is 18F-Fluciclovine (Axumin) safe for use in humans?

Research indicates that 18F-Fluciclovine (Axumin) has been evaluated for safety in various clinical trials, including those for brain tumors and prostate cancer. These studies generally support its safety as a PET/CT imaging agent in humans. ^{1 2 4 5 6}

How does Axumin PET-CT differ from other brain cancer treatments?

Axumin PET-CT uses a special tracer called 18F-fluciclovine to help visualize brain tumors more effectively than some other imaging methods, which can have limitations. This makes it unique in its ability to provide clearer images for diagnosing and assessing brain cancer. ^{1 2 3 6 7}

Research Team

Yang Lu, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Phase IIa clinical study of [18F]fluciclovine: efficacy and safety of a new PET tracer for brain tumors. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Incidental Serous Cystadenoma Presenting as a Photopenic Pancreatic Defect on 18F-Fluciclovine PET/CT. [2023]

3. United States 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. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Metastatic Male Breast Cancer With Increased Uptake on 18F-Fluciclovine PET/CT Scan. [2018]

5. Germany 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. [2021]

6. Japan 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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