Advanced Imaging for Glioblastoma

(GBM Trial)

Recruiting at 1 trial location

Overseen By Jeremy T Westerman, B.S.

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Pregnancy, Breastfeeding, MRI contraindications, 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: 7

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand glioblastoma, a type of brain cancer, through advanced imaging techniques. Researchers will use special scans, including Fluciclovine F18 (also known as Axumin, a diagnostic imaging agent), to study the metabolism of brain tumors and compare this data with lab tests on tumor samples. The trial seeks individuals with a new brain mass suspected to be glioblastoma or changes in a previously diagnosed glioblastoma. Participants should be preparing for surgery and able to undergo imaging procedures. As an Early Phase 1 trial, this research focuses on understanding how the imaging agent functions in people, offering participants a chance to contribute to groundbreaking insights in glioblastoma diagnosis.

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 this imaging method is safe for glioblastoma patients?

Research has shown that Fluciclovine F18, also known as Axumin, has undergone safety testing in various studies, including those on brain tumors and prostate cancer. The FDA has approved it for certain uses, indicating it has passed safety checks for those conditions.

Studies have found no major safety differences between older and younger adults using Fluciclovine F18. No specific situations are known where this treatment is advised against. Although information on its use in children is limited, adults have generally tolerated it well.

Overall, past research suggests that Fluciclovine F18 is safe for adults, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fluciclovine F18 is unique because it uses a novel imaging agent to enhance the detection of glioblastoma, a type of brain tumor. Unlike traditional imaging methods, which may rely on contrast agents like gadolinium, Fluciclovine F18 is a radiolabeled amino acid that can provide more precise information about tumor metabolism. This can help in identifying tumor boundaries more accurately and assessing tumor activity, which is crucial for planning effective treatment strategies. Researchers are excited because this could lead to better-targeted therapies and improved outcomes for patients with glioblastoma.

What evidence suggests that this imaging method is effective for glioblastoma?

Research has shown that 18F-fluciclovine is highly effective in detecting glioblastomas, a type of brain tumor. Studies have found it can identify these tumors 100% of the time, making it a promising diagnostic tool. In this trial, participants will join an imaging cohort using 18F-fluciclovine to highlight areas with increased amino acid activity, common in tumor cells. By providing clear images of the tumor area, 18F-fluciclovine aids doctors in planning better treatments. Its ability to detect beyond the obvious changes in the brain makes it a valuable option for those dealing with glioblastoma. ^{1 3 5 6 7}

Who Is on the Research Team?

Ali Nabavizadeh, MD

Principal Investigator

University of Pensylvania

Are You a Good Fit for This Trial?

This trial is for individuals with glioblastoma, a type of brain cancer. It's open to those who are newly diagnosed (treatment naïve) as well as those with recurrent tumors. Specific eligibility details aren't provided, but typically participants must meet certain health standards and not have conditions that would interfere with the study.

Inclusion Criteria

I have been diagnosed with a brain tumor thought to be GBM by a Penn neuroradiologist.

This criterion does not apply to me.

My MRI shows new or worsening brain tumor growth after treatment.

Exclusion Criteria

Females who are pregnant or breastfeeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of childbearing potential prior to injection

Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study

I am over 18 and can understand and agree to the study's terms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Subjects undergo dynamic PET/CT scanning with 18F-Fluciclovine and 18F-FDG, and optional MRI at 7 Tesla for metabolic profiling of glioblastoma

1-2 weeks

Multiple visits within 7 business days

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fluciclovine F18

Trial Overview The study tests how two radioactive drugs, [18F]Fluciclovine and 18F-FDG, are taken up by glioblastoma cells using PET scans. It also uses advanced MRI at 7 Tesla to assess tumor metabolism. Results will be compared to lab assays of tumor tissue.

How Is the Trial Designed?

Group I: Imaging Cohort Experimental Treatment 1 Intervention

Up to 15 subjects will enroll in this imaging study at the University of Pennsylvania. Those with a diagnosis of a new intra-axial brain mass that is consistent with GBM per the opinion of a Penn neuroradiologist OR New contrast-enhancing lesion or lesions showing increased enhancement (\>25% increase) in a patient with a historical diagnosis of glioblastoma.

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Published Research Related to This Trial

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]

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 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]

18F-fluciclovine (18F-FACBC) shows a 100% detection rate in gliomas and glioblastomas, indicating its potential as a highly effective diagnostic tool for these brain tumors.

FACBC PET imaging outperforms traditional MRI in accurately defining tumor extent and volumes, and it offers similar accuracy to methionine with improved tumor-to-background contrast, suggesting it could be a valuable addition to glioma diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-Fluciclovine (18F-FACBC) PET/CT or PET/MRI in gliomas/glioblastomas. Albano, D., Tomasini, D., Bonù, M., et al.[2020]

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 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 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/NCT03990285

[18F]Fluciclovine in Post-treatment Glioblastoma ( Axumin ) Positron emission tomography (PET/CT) imaging will be used to evaluate fluciclovine uptake at sites of suspected progression before planned surgery. In addition ...

2. withpower.com withpower.com/trial/early-phase-1-glioblastoma-9-2024-6fe41

Advanced Imaging for Glioblastoma (GBM Trial) 18F-fluciclovine (18F-FACBC) shows a 100% detection rate in gliomas and glioblastomas, indicating its potential as a highly effective diagnostic tool for these ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/jnumed/early/2022/12/22/jnumed.122.264812.full.pdf

18F-Fluciclovine PET in glioblastoma Amino acid PET imaging enables analysis of the tumor environment beyond disruption of the BBB because it is based on upregulation of amino acid ...

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.829050/full

Imaging Glioblastoma With 18 F-Fluciclovine Amino Acid ... Positron emission tomography (PET) with 18 F-fluciclovine (fluciclovine) provides regional assessment of amino acid uptake in tumors.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7081387/

PET fusion with MRI guides neurosurgical sampling A combined 18 F-fluciclovine PET-MRI–guided approach can guide neurosurgical resection of viable recurrent glioblastoma in the background of treatment-related ...

6. axumin.com axumin.com/about/safety-side-effects

Axumin® (fluciclovine F 18) injection | Safety & Side Effects Axumin has no contraindications. No overall differences in safety or effectiveness were observed between older adults and younger subjects.

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

Clinical Practice Guidelines for 18F-Fluciclovine 2024 in the ... There are no data regarding the efficacy or safety of this examination in pediatric patients. Patient management (During Waiting Time). Since ...