18F-Fluciclovine PET/CT for Brain Cancer

Overseen By Sarah A Fermawi, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Arizona

Disqualifiers: Recent brain biopsy, Prior brain surgery, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this diagnostic intervention clinical trial is to compare 18F-Fluciclovine uptake within brain lesions over 60 minutes compared with standard of care positive histology confirmation or confirmation MRI images. The main questions it aims to answer are: 1. What are the dynamics of 18F-Fluciclovine update within a non-treated metastatic brain lesion over 60 minutes? 2. What are the dynamics of 18F-fluciclovine update within recently treated metastatic brain lesions? 3. What is the potential use of 18F-Fluciclovine in delineating true local progression from radionecrosis in patients with clinical uncertainty of indeterminate MRI? Participants will undergo an 18F-fluciclovine head PET/CT scan prior to treatment for brain metastatic lesion(s). The study will characterize uptake dynamic PET images over 60 minutes. Uptake within the lesions and the benign brain parenchyma will be plotted on a time activity curve for 60 mins. Patients will undergo a second 18F-fluciclovine PET/CT to evaluate 18F-fluciclovine uptake in treated lesions over 60 minutes. This will be offered concurrently with the post-procedure standard of care (SOC) MRI to evaluate post-treatment changes. Uptake within the lesions and the benign brain parenchyma will be plotted on a 60 min time activity curve. Results will be compared to the pre-treatment baseline images. A third 18F-fluciclovine PET/CT will be offered to evaluate post radiation changes necrosis from recurrence, for up to 10 patients in our cohort who are under clinical surveillance (up to three years surveillance) and developed MRI evidence of either true progression or radionecrosis with clinical uncertainty after stereotactic radiosurgery. The initial 18F-fluciclovine PET/CT will serve as a baseline PET/CT scan. This will be compared to post procedural histological confirmation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor to get a clear answer.

What data supports the effectiveness of the drug 18F-Fluciclovine PET/CT for brain cancer?

Research shows that 18F-Fluciclovine PET/CT is effective in diagnosing brain tumors like gliomas, with high accuracy in detecting tumor extent and distinguishing between low-grade and high-grade gliomas. It has been found to provide better tumor-to-background contrast compared to other imaging methods, making it a promising tool for brain cancer diagnosis. ^{1 2 3 4 5}

How does the drug 18F-Fluciclovine PET/CT differ from other treatments for brain cancer?

18F-Fluciclovine PET/CT is unique because it uses a synthetic amino acid radiotracer to visualize brain tumors, offering a novel method for diagnosing gliomas where traditional imaging methods may fall short. This drug is particularly effective in assessing amino acid transport into cells, which is crucial for identifying and evaluating brain cancer. ^{2 3 5 6 7}

Research Team

Bital Savir-Baruch, MD

Principal Investigator

University of Arizona

Eligibility Criteria

This trial is for adults over 18 with suspected or confirmed brain metastases from known cancer, who've had a positive MRI within the last two months and are scheduled for brain lesion treatment. They must be able to lie still for a PET/CT scan and sign consent. Excluded are those treated after their last MRI, with recent biopsies, prior brain surgery or radiation on the lesion, or unable to tolerate the exam.

Inclusion Criteria

I am 18 years old or older.

I have a history of cancer.

I can lie still on my back for a PET/CT scan.

Exclusion Criteria

You cannot undergo the 18F-fluciclovine PET/CT exam.

Concurrent or prior enrollment on other clinical trials would not exclude patients, as long as all other eligibility criteria are met

I have had brain surgery or radiation for my current brain tumor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline PET/CT Scan

Participants undergo an initial 18F-fluciclovine PET/CT scan to characterize uptake dynamics within brain lesions over 60 minutes

1 day

1 visit (in-person)

Post-Treatment PET/CT Scan

Participants undergo a second 18F-fluciclovine PET/CT scan to evaluate uptake in treated lesions over 60 minutes, concurrent with post-procedure SOC MRI

2 months from baseline

1 visit (in-person)

Follow-up PET/CT Scan

A third 18F-fluciclovine PET/CT scan is offered to evaluate post-radiation changes and differentiate necrosis from recurrence for patients under clinical surveillance

Up to 3 years from baseline

1 visit (in-person) for up to 10 patients

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

Interventions

• 18F-Fluciclovine PET/CT

Trial Overview The trial tests how well an imaging agent called 18F-Fluciclovine shows up in brain lesions using PET/CT scans. It compares uptake dynamics before and after treatment like surgery or radiation therapy against standard MRI results to distinguish true progression of disease from tissue damage due to treatment.

Participant Groups

Group I: 18F-Fluciclovine (Axumin) PET/CT Experimental Treatment 1 Intervention

Patients with recently diagnosed brain metastatic lesion(s) will be recruited based on MRI with or without histological confirmation, per standard of care. All patients will undergo an 18F-fluciclovine head PET/CT scan prior to treatment for brain metastatic lesions, post treatment, and 3 years post treatment.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Blue Earth Diagnostics

Industry Sponsor

Trials

43

Recruited

3,100+

Findings from Research

18F-fluciclovine (18F-FACBC) shows a 100% detection rate in gliomas and glioblastomas, indicating its potential as a highly effective diagnostic tool for these brain tumors.

FACBC PET imaging outperforms traditional MRI in accurately defining tumor extent and volumes, and it offers similar accuracy to methionine with improved tumor-to-background contrast, suggesting it could be a valuable addition to glioma diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-Fluciclovine (18F-FACBC) PET/CT or PET/MRI in gliomas/glioblastomas. Albano, D., Tomasini, D., Bonù, M., et al.[2020]

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]

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 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]

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 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]

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

18F-Fluciclovine (18F-FACBC) PET/CT or PET/MRI in gliomas/glioblastomas. [2020]

2. 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]

3. 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]

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

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

5. 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]

6. 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]

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]