18F-Fluciclovine PET-MRI for Brain Tumor

Recruiting at 1 trial location

Overseen by Mariam Aboian, MD,PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Pregnancy, Abnormal kidney function, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if a special imaging agent called 18F-Fluciclovine (Axumin®) can help manage brain tumors in children. The agent is used in scans to make tumors more visible. Doctors will compare these images periodically to see how well the treatment is working.

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 data supports the effectiveness of the drug 18F-Fluciclovine for brain tumors?

Research shows that 18F-Fluciclovine PET imaging is effective in detecting brain tumor regions that might not be visible on regular MRI scans. It has demonstrated diagnostic efficacy for brain cancers, especially where other imaging methods have limitations. ^{1 2 3 4 5}

Is 18F-Fluciclovine safe for use in humans?

A study evaluating 18F-Fluciclovine for brain tumors (gliomas) included an assessment of its safety, suggesting that it has been considered safe for use in humans. ^{4 6 7 8 9}

How is the drug 18F-Fluciclovine PET-MRI unique for brain tumor treatment?

18F-Fluciclovine PET-MRI is unique because it uses a special radiotracer that helps detect brain tumor regions that might not be visible on regular MRI scans. This drug is particularly useful for diagnosing gliomas, a common type of brain tumor, and offers a more detailed view of the tumor's extent compared to other imaging methods. ^{1 4 6 10 11}

Research Team

Mariam Aboian, MD,PhD

Principal Investigator

The Children s Hospital of Philadelphia

Eligibility Criteria

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

Pregnant participants

Trial Timeline

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

Treatment Details

Interventions

• 18F-Fluciclovine (Radiopharmaceutical)

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.

Participant Groups

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+

Joseph W. St. Geme III

Children's Hospital of Philadelphia

Chief Medical Officer since 2021

MD, PhD, MPH

Madeline Bell

Children's Hospital of Philadelphia

Chief Executive Officer since 2015

BSc in Nursing from Villanova University, MSc in Organizational Dynamics from the University of Pennsylvania

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+

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]

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]

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]

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]

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]

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]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Exploratory Analysis of Serial 18F-fluciclovine PET-CT and Multiparametric MRI during Chemoradiation for Glioblastoma. [2022]

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

18F-Fluciclovine PET/CT in Suspected Residual or Recurrent High-Grade Glioma. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. Germany pubmed.ncbi.nlm.nih.gov

18F-Fluciclovine (18F-FACBC) PET imaging of recurrent brain tumors. [2023]

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

Incidental Serous Cystadenoma Presenting as a Photopenic Pancreatic Defect on 18F-Fluciclovine PET/CT. [2023]

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

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

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

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

9. Iran 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. [2023]

10. 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]

11. 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]