18F-Fluciclovine PET for Brain Cancer

(FACILITATE Trial)

Overseen By Antoinette Pimental

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Baptist Health South Florida

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

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special scan, 18F-Fluciclovine PET (also known as Axumin), can help doctors assess brain cancer's response to stereotactic radiosurgery (SRS). The scan occurs twice: once during treatment planning and again about eight weeks after SRS to check for changes. Individuals with brain cancer that has spread, whose tumors are no larger than 2 cm, and who are scheduled to receive SRS may be suitable candidates for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

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 prior data suggests that 18F-Fluciclovine PET imaging is safe for brain cancer patients?

Research shows that 18F-Fluciclovine PET scans are generally easy for adults to handle. Studies have found that this imaging method can effectively find tumors without causing major side effects. One study showed that 18F-Fluciclovine PET could distinguish between tumor growth and treatment-induced changes in the brain. This distinction is crucial for assessing treatment effectiveness.

Although data on 18F-Fluciclovine remains limited, existing research suggests it is safe. Studies using this imaging technique for brain conditions have reported no major negative effects. This indicates that 18F-Fluciclovine is safe for people, with few, if any, side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for brain cancer, which often includes surgery, radiation, and chemotherapy, 18F-fluciclovine PET imaging offers a novel approach by using a specialized radioactive tracer to map cancer activity in the brain. This imaging technique is unique because it highlights metabolic activity of cancer cells, providing a more detailed view of tumor biology than traditional MRI scans. Researchers are excited about this technique as it could lead to more precise treatment planning and potentially improve outcomes by better targeting radiation therapy.

What evidence suggests that 18F-Fluciclovine PET is effective for measuring brain metastasis response after SRS?

Research has shown that 18F-Fluciclovine PET scans, which participants in this trial will undergo, effectively detect brain tumors. Studies indicate these scans can correctly identify high-grade gliomas 85.7% to 100% of the time, with an average accuracy of 92.9%. This demonstrates their proficiency in detecting tumors. Additionally, 18F-Fluciclovine excels at distinguishing between tumor growth and other changes after radiation treatment, with some studies showing 100% accuracy. Overall, this evidence suggests that 18F-Fluciclovine PET scans could reliably check for brain tumors after radiosurgery. ^{2 5 6 7 8}

Who Is on the Research Team?

Rupesh R Kotecha, MD

Principal Investigator

Miami Cancer Institute at Baptist Health, Inc.

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• 18F fluciclovine

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

Citations

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

Diagnostic Accuracy of PET with 18F-Fluciclovine ([18F ... The sensitivity of [18F]FACBC PET/CT or PET/MRI for detecting HGG ranged from 85.7% to 100%, with a pooled estimate of 92.9% (95% CI: 84.4–96.9 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03276676

[18F]Fluciclovine and [18F]FLT PET/CT Assessment of ... Improvements in the ability to predict tumor behavior prior to the start of therapy would allow more efficient and effective tumor surveillance; better ...

3. withpower.com withpower.com/trial/phase-neoplasm-metastasis-1-2024-fd33f

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 ...

4. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/18f-fluciclovine-pet-ct-helps-distinguish-radiation-necrosis-from-brain-tumor-progression

18F Fluciclovine PET CT Helps Distinguish Radiation ... “When we used fluciclovine, our ability to identify tumor progression was very good — it was 100%,” says Dr. Chao. “Our ability to rule out ...

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

Evaluating the diagnostic performance of 18 F-fluciclovine ... This is the first prospective multicenter trial to evaluate PET characteristics of suspected recurrent BM after RT, verified by histopathology.

6. 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 ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/60/supplement_1/496

Safety and effectiveness of 18 F-fluciclovine PET in adults with ... Conclusions: 18F-Fluciclovine PET is well tolerated and able to effectively detect the presence of tumors in adults with recurrent gliomas.

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

Clinical Practice Guidelines for 18F-Fluciclovine 2024 in ... This guideline provides a comprehensive overview of the clinical characteristics of 18F-Fluciclovine in malignant glioma, including indications ...