PET-MRI with Axumin for Brain Tumor

Recruiting in Palo Alto (17 mi)

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: Pregnant, Breastfeeding, Abnormal kidney function, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a special scan to help doctors see if brain tumors in children are growing again or if changes are just from treatment. This can help doctors decide the best next steps for treatment. The scan has shown utility in detecting prostate cancer and is being explored for other cancers.

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 data supports the effectiveness of the treatment 18F-Fluciclovine PET-MRI 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, and it has demonstrated diagnostic efficacy for brain cancers where other imaging methods fall short. ^{1 2 3 4 5}

Is 18F-Fluciclovine PET-MRI (Axumin) safe for humans?

18F-Fluciclovine (Axumin) has been widely used and approved for detecting prostate cancer recurrence, indicating it is generally considered safe for human use in this context. ^{2 3 4 6 7}

How does the PET-MRI with Axumin treatment for brain tumors differ from other treatments?

PET-MRI with Axumin (18F-fluciclovine) is unique because it combines PET imaging, which shows cellular activity and metabolism, with MRI, which provides detailed anatomical images. This combination can detect brain tumor regions that might be missed by standard MRI alone, offering a more comprehensive assessment of the tumor burden. ^{1 2 3 8 9}

Research Team

Mariam Aboian, MD,PhD

Principal Investigator

children&#39;s hospital of philadelphia

Eligibility Criteria

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 between 1 and 21 years old.

I am suspected of cancer progression but haven't had my first MRI after radiation.

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

Trial Timeline

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

Treatment Details

Interventions

• 18F-Fluciclovine PET-MRI (Radiopharmaceutical)

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.

Participant Groups

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+

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 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 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 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 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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

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

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

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

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

5. 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]

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

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

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

Complementary Role of 18 F-Fluciclovine PET/CT and 18 F-NaF PET/CT in Detecting Prostate Cancer Metastasis. [2023]

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

Multimodal 18F-Fluciclovine PET/MRI and Ultrasound-Guided Neurosurgery of an Anaplastic Oligodendroglioma. [2017]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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