18F-Fluciclovine PET-MRI for Brain Tumor

Recruiting at 1 trial location

Overseen By Nazanin Maleki, MD

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Pregnancy, Abnormal kidney function, 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: 4

Duration: 1 year

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special imaging method using 18F-Fluciclovine (also known as Axumin) can help manage children with low-grade gliomas, a type of brain tumor. Researchers will perform scans before treatment, then at three months and one year after treatment begins, to compare this imaging with traditional MRI scans. The goal is to determine if this imaging is both useful and safe. Children diagnosed with low-grade gliomas and set to start treatment may be suitable candidates for this trial. As an Early Phase 1 trial, this research focuses on understanding how the imaging method works in children, offering participants a chance to contribute to groundbreaking advancements in brain tumor management.

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

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that 18F-Fluciclovine PET-MRI is safe for children with Low Grade Gliomas?

Research has shown that 18F-Fluciclovine, also known as Axumin®, is generally safe in imaging studies. This substance is mainly used in PET scans to detect tumors, such as those in the prostate and brain. Previous studies with patients have not reported any major safety issues. Notably, the FDA has already approved this imaging agent for certain cancer imaging, indicating its likely safety. However, since this is an early phase trial, the researchers are still collecting detailed safety information specifically for brain tumor imaging in children. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for brain tumors?

Most treatments for brain tumors involve surgery, radiation, and chemotherapy, which can be invasive and have significant side effects. Unlike these options, 18F-Fluciclovine PET-MRI offers a non-invasive method to specifically image brain tumors. This innovative approach uses 18F-Fluciclovine, a radiotracer, to highlight cancerous cells during PET-MRI scans, potentially allowing for more precise diagnosis and monitoring. Researchers are excited about this technique because it could improve the accuracy of tumor detection and characterization without the need for invasive procedures.

What evidence suggests that 18F-Fluciclovine PET-MRI is effective for managing Low Grade Gliomas?

Research has shown that 18F-Fluciclovine PET imaging, which participants in this trial will undergo, could aid in diagnosing and managing brain tumors, particularly aggressive ones like high-grade gliomas. Studies suggest it can help detect tumor recurrence. While most research has focused on these aggressive tumors, there is hope it might also assist with less aggressive ones, known as low-grade gliomas. This method uses a special tracer to highlight tumor activity in PET-MRI scans, making it easier for doctors to track changes over time. Although limited data exists on low-grade gliomas, this imaging method is considered safe and potentially useful for similar conditions. ^{2 5 6 7 8}

Who Is on the Research Team?

Mariam Aboian, MD,PhD

Principal Investigator

The Children s Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for children and young adults aged 1 to 21 with Low Grade Gliomas (brain tumors). They must have a tumor visible on MRI, be scheduled for systemic therapy, and have a certain level of physical ability. It's not for pregnant individuals, those needing extra sedation for scans, with kidney issues or very low body weight, or who can't avoid contact with infants/pregnant women post-injection.

Inclusion Criteria

My low-grade glioma was confirmed by biopsy or I have NF1 with a typical tumor appearance.

Participants must have evaluable disease (1x1 cm tumor on MRI; enhancing + non-enhancing tumor)

I am between 1 and 21 years old.

Exclusion Criteria

I weigh less than 8 kg.

Inability to tolerate imaging procedures in the opinion of an investigator or treating physician

Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Imaging with 18F-Fluciclovine PET-MRI is performed prior to initiation of therapy

1 week

1 visit (in-person)

Treatment

Participants undergo systemic treatment for LGG with imaging follow-ups

1 year

3 visits (in-person) at baseline, 3 months, and 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• 18F-Fluciclovine

Trial Overview

The study tests the usefulness and safety of a diagnostic agent called 18F-Fluciclovine in PET-MRI scans before treatment starts and then at 3 months and 1 year after therapy begins. The changes in uptake will be compared to MRI measurements over time.

How Is the Trial Designed?

Group I: 18F-Fluciclovine Experimental Treatment 1 Intervention

18F-Fluciclovine PET-MRI

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Blue Earth Diagnostics

Industry Sponsor

Trials

43

Recruited

3,100+

Blue Earth Diagnostics, Inc

Collaborator

Trials

5

Recruited

160+

Dragon Master Foundation

Collaborator

Trials

2

Recruited

60+

Published Research Related to This Trial

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 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]

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 pilot study involving 6 glioblastoma patients undergoing chemoradiotherapy, higher uptake of 18F-fluciclovine PET was associated with poorer prognosis, indicating that this imaging technique may provide valuable insights into tumor activity beyond what is seen with traditional MRI methods.

The study found that in patients with shorter survival, 18F-fluciclovine PET volumes were larger than those measured by dynamic contrast-enhanced MRI (DCE-MRI) and Gd-T1 MRI, while the opposite was true for patients with longer survival, suggesting that 18F-fluciclovine uptake correlates with tumor biology and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory Analysis of Serial 18F-fluciclovine PET-CT and Multiparametric MRI during Chemoradiation for Glioblastoma. Fatania, K., Frood, R., Tyyger, M., et al.[2022]

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 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]

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]

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 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]

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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.

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Anti-1-Amino-3-18F-Fluorocyclobutane-1-Carboxylic Acid

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Fluciclovine (18F) is a radiolabelled L-leucine derivative used to image tumors, especially in the prostate.