Metabolic Profiling of Glioblastoma with Fluciclovine F18 and 18F-FDG PET

This study is looking at people with newly diagnosed glioblastoma or glioblastoma that has come back. It uses special imaging scans called PET scans with two different tracers, Fluciclovine F18 and 18F-FDG, along with advanced MRI scans. The goal is to understand the metabolism (how cells use energy) of these brain tumors. Researchers will compare the information from these scans to lab tests on tumor tissue. This will help them learn more about how glioblastoma cells work. The study aims to enroll 15 participants, and success will be measured by the uptake values from the PET scans over two years.

Study design
This is an interventional study with an estimated enrollment of 15 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo dynamic PET/CT scans with Fluciclovine F18, followed by a break, and then static PET scans with 18F-FDG. An optional 60-minute brain MRI without contrast would also be performed.
Compensation
Not stated in the trial record.
Follow-up
Participants' uptake values from the PET scans will be measured for up to 2 years.

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NCT06613841

Multitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI for Metabolic Profiling of Glioblastoma

Recruiting
EARLY_PHASE1Ages 18+InterventionalDiagnostic
Abramson Cancer Center at Penn Medicine
~15 participants
Updated 2025-11-28 on ClinicalTrials.gov
What's tested:Fluciclovine F18

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Uptake Values (SUV)
Measured over 2 years
Glioblastoma
Recurrent Glioblastoma
Glioblastoma Multiforme of Brain
2 sites across 1 states
Pennsylvania2
  • Ali Nabavizadeh, MD · PRINCIPAL_INVESTIGATOR · University of Pensylvania

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Eligibility criteria

Inclusion

Participants will be ≥ 18 years of age
Diagnosis of a new intra-axial brain mass that is consistent with GBM per the opinion of a Penn neuroradiologist.
New contrast-enhancing lesion or lesions showing increased enhancement (\>25%increase) in a patient with a historical diagnosis of glioblastoma (histologic or molecular proof) on standard MRI after completion of treatment
Recommended for clinically indicated surgical resection
Life expectancy of greater than 3 months in the opinion of an investigator or treating physician.
Karnofsky performance status ≥ 60 per medical record review
Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion

Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
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
Contraindications to MRI
Only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study
  • Uptake Values (SUV)2 years

    Quantification of \[18F\]Fluciclovine and 18F-FDG uptake values (SUV) in treatment naïve and recurrent GBM.