18F-Fluciclovine PET for Brain Cancer

(FACILITATE Trial)

Overseen by Rupesh R Kotecha, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Baptist Health South Florida

Disqualifiers: Leptomeningeal disease, Whole-brain radiation, Pacemaker, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the drug 18F-fluciclovine (Axumin) for brain cancer?

Research shows that 18F-fluciclovine PET is effective in detecting brain tumor regions that are not visible on standard MRI scans, and it has demonstrated diagnostic efficacy for brain cancers where other methods have limitations. ^{1 2 3 4 5}

How is the drug 18F-Fluciclovine PET unique for brain cancer?

18F-Fluciclovine PET is unique for brain cancer because it is a special imaging technique that uses a synthetic amino acid to help visualize brain tumors, especially when other imaging methods like 18F-fludeoxyglucose PET have limitations. This drug is particularly useful for diagnosing gliomas, a type of brain tumor, by highlighting areas of increased amino acid transport, which is often upregulated in cancer cells. ^{1 2 5 6 7}

Research Team

Rupesh R Kotecha, MD

Principal Investigator

Miami Cancer Institute at Baptist Health, Inc.

Eligibility Criteria

This trial is for cancer patients with small brain metastases (≤2cm) who are set to receive stereotactic radiosurgery. They must be in fair health (ECOG 0-2), not pregnant, and agree to use two effective contraception methods. It's not for those allergic to 18F-fluciclovine, unable to have an MRI, breastfeeding without a pause post-imaging, or with major illnesses that affect study participation.

Inclusion Criteria

I am able to get out of my bed or chair and move around.

All my brain tumors are 2 cm or smaller.

My cancer has spread to my brain, confirmed by imaging.

Exclusion Criteria

There is visible evidence of leptomeningeal disease in imaging tests.

I am breastfeeding but can stop for 24 hours after imaging.

If I can't make decisions due to cognitive issues, someone legally allowed can consent for me.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

SRS Planning and Initial PET Imaging

Participants undergo a 18F-fluciclovine PET scan at the time of their SRS planning MRI

1 week

1 visit (in-person)

Stereotactic Radiosurgery (SRS)

Participants undergo single-fraction SRS as standard of care

1 day

1 visit (in-person)

Post-SRS PET Imaging

A second 18F-fluciclovine PET scan is completed 8 weeks (± 2 weeks) after SRS

8 weeks

1 visit (in-person)

Follow-up

Participants are monitored for tumor control and progression according to RANO criteria

12 months

Treatment Details

Interventions

• 18F fluciclovine (Radiopharmaceutical)

Trial Overview The study tests if the imaging agent 18F-Fluciclovine PET can track how well brain metastases respond after being treated with stereotactic radiosurgery—a precise radiation therapy aimed at tumors in the brain.

Participant Groups

Group I: 18F-Fluciclovine PET Imaging Experimental Treatment 1 Intervention

Participants will undergo a 18F-fluciclovine PET scan at the time of their SRS planning magnetic resonance imaging (MRI). Then participants will undergo single-fraction SRS as standard of care (SOC). A second 18F-fluciclovine PET scan will be completed 8 weeks (± 2 weeks) after SRS.

Who Is Running the Clinical Trial?

Baptist Health South Florida

Lead Sponsor

Trials

54

Recruited

8,100+

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]

In a study involving 13 rats with implanted glioblastoma cells, [18F]fluciclovine PET showed similar sensitivity for detecting tumor burden compared to conventional MRI, with median sensitivities of 0.67 for PET and 0.61 for MRI.

Combining [18F]fluciclovine PET with MRI significantly improved detection sensitivity to 0.86, which was 41% higher than MRI alone, indicating that using both imaging techniques together may enhance the assessment of brain tumor burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI and amino acid PET detection of whole-brain tumor burden. Chen, P., Scarpelli, ML., Healey, DR., et al.[2023]

The PET tracer 18F-fluciclovine (Axumin) has been approved for use in men suspected of having recurrent prostate cancer after previous treatment, indicating its potential role in improving diagnosis.

Studies utilizing systematic sector-based histopathology as a reference standard have been conducted to evaluate the diagnostic accuracy of 18F-fluciclovine PET, highlighting its importance in clinical settings for prostate cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-Fluciclovine PET for Assessment of Prostate Cancer with Histopathology as Reference Standard: A Systematic Review. Seierstad, T., Hole, KH., Tulipan, AJ., et al.[2021]

FACBC-PET imaging demonstrated higher contrast in detecting gliomas compared to L-methyl-11C-methionine (MET)-PET, suggesting it may be more effective for glioma diagnosis.

In a study involving six patients suspected of having gliomas, FACBC showed higher lesion-to-normal brain tissue ratios than MET, indicating better assessment capabilities for glioma detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis of Brain Tumors Using Amino Acid Transport PET Imaging with 18F-fluciclovine: A Comparative Study with L-methyl-11C-methionine PET Imaging. Tsuyuguchi, N., Terakawa, Y., Uda, T., et al.[2020]

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 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]

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. Switzerland pubmed.ncbi.nlm.nih.gov

MRI and amino acid PET detection of whole-brain tumor burden. [2023]

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

18F-Fluciclovine PET for Assessment of Prostate Cancer with Histopathology as Reference Standard: A Systematic Review. [2021]

5. Iran pubmed.ncbi.nlm.nih.gov

Diagnosis of Brain Tumors Using Amino Acid Transport PET Imaging with 18F-fluciclovine: A Comparative Study with L-methyl-11C-methionine PET Imaging. [2020]

6. 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]

7. 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]