18F-Fluciclovine Imaging for Brain Tumors

(CONCORDANT Trial)

Overseen By Antoinette Pimentel

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Baptist Health South Florida

Disqualifiers: Leptomeningeal disease, Prior whole-brain radiation, 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 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging agent, 18F-Fluciclovine, to determine if it can identify brain tumors more effectively after surgery than an MRI alone. It targets individuals who have undergone surgery to remove brain metastases and plan to receive targeted radiation treatment afterward. The study aims to help doctors detect any remaining tumors and identify potential recurrences more effectively. Individuals diagnosed with brain metastasis and scheduled for surgery followed by stereotactic radiosurgery (SRS) might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in brain tumor imaging.

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

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.

What prior data suggests that 18F-Fluciclovine is safe for imaging brain tumors?

Research has shown that 18F-Fluciclovine has been used in imaging for other cancers, such as prostate and breast cancer, helping doctors see tumors more clearly. In these studies, patients generally tolerated 18F-Fluciclovine well, with few reports of serious side effects, and most patients did not experience major problems.

This trial is in an early phase, meaning the treatment is still being tested for safety in brain tumor imaging. The goal is to determine its effectiveness and safety for patients. While some information exists from other cancer types, it's important to remember that brain tumors might react differently. However, the use of 18F-Fluciclovine in imaging other cancers is a positive sign for its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-Fluciclovine for brain tumors because it offers a new way to visualize tumor activity and potential recurrence risks. Unlike traditional imaging methods that primarily rely on structural details from MRI, 18F-Fluciclovine PET/CT provides metabolic insights, potentially identifying regions at risk of failure and monitoring tumor control more effectively. This approach could lead to better-targeted treatments and improved outcomes by detecting changes in tumor metabolism earlier than existing options.

What evidence suggests that 18F-Fluciclovine imaging is effective for evaluating brain tumors?

Research has shown that 18F-Fluciclovine is a promising tool for detecting brain tumors. Some studies suggest it can better identify high-grade gliomas, a type of brain tumor, by providing clearer images than an MRI alone. In this trial, all participants will receive an 18F-Fluciclovine PET/CT scan in addition to the planning MRI during SRS treatment. This imaging agent highlights areas in the brain with unusual cell activity, helping doctors see the full size of a tumor or detect any recurrence. While researchers continue to study its use for brain metastases, early results are promising for improving tumor detection. ^{2 6 7 8 9}

Who Is on the Research Team?

Rupesh R Kotecha, MD

Principal Investigator

Miami Cancer Institute/Baptist Health South Florida

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had brain surgery to remove metastasis and are set for follow-up radiosurgery. They must be in a stable enough condition (ECOG 0-3) and agree to use two effective contraception methods if of reproductive potential. It's not for those with prior whole-brain radiation, MRI contraindications, pregnancy during the study period, breastfeeding without pausing it post-imaging, previous severe reaction to 18F-Fluciclovine or leptomeningeal disease.

Inclusion Criteria

I have been diagnosed with brain metastasis through imaging tests.

I am scheduled for radiation therapy after surgery.

I can care for myself but may not be able to do heavy physical work.

Exclusion Criteria

My cancer has spread to the lining of my brain and spinal cord.

Prior anaphylactic reaction to 18F-Fluciclovine

I have had whole-brain radiation therapy before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Imaging

Optional pre-surgery 18F-Fluciclovine PET/CT scan to evaluate the extent of surgery

1 day

1 visit (in-person)

SRS Treatment Planning

18F-Fluciclovine PET/CT scan in addition to planning MRI at the time of SRS treatment

Approximately 2-4 weeks after resection

1 visit (in-person)

Follow-up

Participants undergo routine follow-up with 18F-Fluciclovine PET/CT and MRI to monitor resection beds for tumor control and detect patterns of failure

12 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 18F-Fluciclovine

Trial Overview The trial tests an imaging agent called 18F-Fluciclovine in patients after brain metastasis surgery but before stereotactic radiosurgery. The aim is to see if this agent can better reveal remaining tumor tissue compared to standard MRI and help detect recurrence more effectively.

How Is the Trial Designed?

Group I: PET/CT, MRI Experimental Treatment 1 Intervention

All patients will obtain an 18F-Fluciclovine PET/CT scan in addition to the planning MRI at the time of SRS treatment (approximately 2-4 weeks after resection). The value of 18F-Fluciclovine in addition to structural information from the MRI will be analyzed. Patients will continue to undergo 18F-Fluciclovine in addition to MRI during routine follow-up to determine the ability of 18F-Fluciclovine PET/CT to identify areas at risk for marginal failure, monitor resection beds for tumor control, identify patients at risk for disease recurrence, and detect patterns of failure.

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 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 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 study of 27 patients with recurrent gliomas, 18F-Fluciclovine PET imaging was positive for all patients, while contrast-enhanced MRI was indeterminate for three, highlighting 18F-Fluciclovine's potential as a reliable imaging tool when MRI results are unclear.

18F-Fluciclovine provided significantly higher image contrast compared to 11C-Methionine due to its lower background uptake in normal brain tissue, making it a promising option for better tumor visualization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-Fluciclovine (18F-FACBC) PET imaging of recurrent brain tumors. Michaud, L., Beattie, BJ., Akhurst, T., et al.[2023]

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 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]

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]

F-fluciclovine PET/CT shows high uptake in patients with suspected recurrent high-grade glioma (HGG), effectively identifying tumors with a median lesion-to-background ratio of 21.6, which is significantly higher than other amino acid PET tracers.

In this study of 21 patients, F-fluciclovine PET/CT successfully detected small satellite tumors not visible on MRI in 4 cases, highlighting its potential for improved tumor detection, although its ability to differentiate between tumor recurrence and treatment-related changes remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-Fluciclovine PET/CT in Suspected Residual or Recurrent High-Grade Glioma. Bogsrud, TV., Londalen, A., Brandal, P., et al.[2020]

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 31 rats with human glioblastoma cell lines, fluciclovine PET imaging showed increased uptake associated with higher levels of the amino acid transporter ASCT2, indicating its potential for assessing brain tumor metabolism.

Fluciclovine PET was effective in visualizing both enhancing and non-enhancing tumors, with greater uptake observed in larger tumors and those with gadolinium enhancement, suggesting these factors should be considered when interpreting PET results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging Glioblastoma With 18F-Fluciclovine Amino Acid Positron Emission Tomography. Scarpelli, ML., Healey, DR., Mehta, S., 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]

The novel tracer 18F-fluciclovine (anti-[18F]FACBC) demonstrated a 100% positive predictive value for detecting gliomas in areas not visible on standard contrast-enhanced MRI, indicating its high diagnostic accuracy.

The tracer was well tolerated among patients, with only 17.5% experiencing mild adverse events, none of which were serious, suggesting it is a safe option for glioma imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Performance and Safety of Positron Emission Tomography Using 18F-Fluciclovine in Patients with Clinically Suspected High- or Low-grade Gliomas: A Multicenter Phase IIb Trial. Wakabayashi, T., Iuchi, T., Tsuyuguchi, N., et al.[2023]

Citations

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Fluciclovine, Anti-1-Amino-3-[ 18 F]-Fluorocyclobutane-1- ... Because the radiotracer is new, very little is known about the utility of this tracer in brain tumors. Case description: We present 3 cases of meningioma with ...

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Clinical Practice Guidelines for 18F-Fluciclovine 2024 in ... 18F-Fluciclovine was the first 18F-labeled amino acid PET tracer to be approved for clinical use in Japan, receiving regulatory approval in ...

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Diagnostic Accuracy of PET with 18F-Fluciclovine ([18F] ... Our aim is to evaluate the diagnostic performance of [ 18 F]FACBC PET in high-grade glioma (HGG) patients, taking into account the literature data.

4. 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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7188736/

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

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4844004/

Anti-1-Amino-3-18F-Fluorocyclobutane-1-Carboxylic Acid Anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid (18F-FACBC) is a synthetic amino acid analog PET radiotracer undergoing clinical trials for the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12378485/

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

8. jnm.snmjournals.org jnm.snmjournals.org/content/55/12/1986

Anti-1-Amino-3-18F-Fluorocyclobutane-1-Carboxylic Acid On the basis of published and unpublished data, 18F-FACBC has demonstrated elevated uptake in carcinomas of the prostate, breast, and lung, as ...

9. go.drugbank.com go.drugbank.com/drugs/DB13146

Fluciclovine (18F): Uses, Interactions, Mechanism of Action Fluciclovine (18F) is a radiolabelled L-leucine derivative used to image tumors, especially in the prostate.