PET-MRI with Axumin for Brain Tumor

Overseen By Mariam Aboian, MD, PhD

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Pregnant, Breastfeeding, 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: 1

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether a special type of PET-MRI scan with 18F-fluciclovine (Axumin®) can safely assist doctors in managing brain tumors in children. The goal is to determine if this imaging can better identify whether changes in the tumor result from actual growth or temporary changes after treatment. The study seeks children diagnosed with high-grade gliomas (an aggressive type of brain tumor) with tumors at least 1 cm in size. Participants must be able to undergo imaging and are expected to live for more than eight weeks. As an Early Phase 1 trial, this research focuses on understanding how this imaging technique works in children, offering participants a chance to contribute to groundbreaking advancements in pediatric brain tumor management.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that 18F-Fluciclovine PET-MRI is safe for children with high-grade gliomas?

Research has shown that 18F-fluciclovine PET-MRI is generally safe for individuals with high-grade gliomas, a type of brain tumor. Most patients tolerate it well, and no major safety issues have been reported. This imaging method uses a small amount of radioactive material to help doctors distinguish between tumor growth and other changes after treatment. Although data remains limited, existing research supports its safe use in these cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 18F-Fluciclovine PET-MRI for brain tumors because it offers a new way to visualize tumors more accurately. Unlike standard imaging techniques that might not clearly distinguish tumor tissue from surrounding healthy tissue, 18F-Fluciclovine is a radiotracer that targets amino acid transporters, which are often more active in tumor cells. This leads to clearer, more precise imaging, potentially allowing for better treatment planning and monitoring. The promise of more accurate imaging could lead to improved outcomes for patients with challenging brain tumors like pediatric high-grade gliomas or diffuse midline gliomas.

What evidence suggests that 18F-Fluciclovine PET-MRI is effective for managing high-grade gliomas in children?

Research has shown that 18F-Fluciclovine PET imaging, which participants in this trial will receive, can detect brain tumor areas that regular MRI scans might miss. Studies have found this method effective in identifying high-grade gliomas, aggressive brain tumors. By using 18F-fluciclovine, a type of radioactive tracer, doctors can distinguish between tumor growth and other post-treatment changes. This distinction is crucial for planning treatments for children with high-grade gliomas. Overall, early evidence suggests it is a promising tool for improved diagnosis and monitoring of these tumors. ^{1 2 3 5 6}

Who Is on the Research Team?

Mariam Aboian, MD,PhD

Principal Investigator

children&#39;s hospital of philadelphia

Are You a Good Fit for This Trial?

This trial is for children and young adults aged between 1 to 21 with high-grade gliomas (brain tumors) who are suspected of tumor progression. They must have a measurable disease, confirmed histopathology or characteristic imaging for DIPG, and a life expectancy over 8 weeks. It's not suitable for those unable to tolerate imaging procedures, under sedation beyond standard care, weighing less than 8 kg, or in close contact with pregnant women/infants post-injection.

Inclusion Criteria

Life expectancy of greater than 8 weeks

I am suspected to have tumor growth and am planned for surgery or biopsy.

I am between 1 and 21 years old.

Exclusion Criteria

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

I weigh less than 8 kg.

Pregnant or breastfeeding participants

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Single intravenous administration of 18F fluciclovine for PET-MRI Scan

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular imaging and safety assessments

What Are the Treatments Tested in This Trial?

Interventions

• 18F-Fluciclovine PET-MRI

Trial Overview The study tests the usefulness and safety of an imaging technique called 18F-fluciclovine PET-MRI in managing high-grade gliomas in children. The goal is to see if this method can accurately distinguish between actual tumor growth and changes that might look like progression but aren't harmful after treatment.

How Is the Trial Designed?

Group I: 18F-Fluciclovine PET-MRI in pediatric HGG or DMG participants Experimental Treatment 1 Intervention

Single intravenous administration of 18F fluciclovine for PET-MRI Scan

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 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 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 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 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 use of simultaneous PET/MRI with the amino acid tracer 18F-fluciclovine in a patient with glioma demonstrated its potential to enhance the accuracy of histopathologic tissue sampling by identifying the most malignant tumor regions, which could improve treatment targeting.

Histopathologic analysis revealed that areas with higher 18F-fluciclovine uptake corresponded to more aggressive tumor characteristics, suggesting that this imaging technique could help in better grading gliomas and guiding surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal 18F-Fluciclovine PET/MRI and Ultrasound-Guided Neurosurgery of an Anaplastic Oligodendroglioma. Karlberg, A., Berntsen, EM., Johansen, H., 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]

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]

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]

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]

Citations

1. 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.

2. trials.braintumor.org trials.braintumor.org/trials/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.

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

Diagnostic Accuracy of PET with 18F-Fluciclovine ([18F ... Evidence-based data demonstrate the good diagnostic accuracy of [ 18 F]FACBC PET for HGG detection.

4. withpower.com withpower.com/trial/early-phase-1-diffuse-glioma-9-2022-032a0

PET-MRI with Axumin for Brain Tumor Research shows that 18F-Fluciclovine PET imaging is effective in detecting brain tumor regions that might not be visible on regular MRI scans, and it has ...

5. cancer.gov cancer.gov/clinicaltrials/NCI-2023-06719

Evaluation of 18F-Fluciclovine PET-MRI to Differentiate ... Using the radioactive tracer, 18F-fluciclovine, with PET-MRI may be a useful and safe diagnostic tool to differentiate tumor progression from post-treatment ...

6. ejnmmires.springeropen.com ejnmmires.springeropen.com/articles/10.1186/s13550-018-0415-3

[18F]Fluciclovine PET discrimination between high- and low ... Fluciclovine PET produces high-contrast images between both low-grade and high grade gliomas and normal brain by visual and semiquantitative analysis.