NCT06613841 · Abramson Cancer Center at Penn Medicine
Multitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI for Metabolic Profiling of Glioblastoma
(GBM)
What this study is about
* To perform metabolic phenotyping of treatment naïve and recurrent GBM by multitracer \[18F\]Fluciclovine and 18F-FDG PET. * To compare uptake measures of 18F-Fluciclovine and 18F-FDG and MRI quantification of glutamate and lactate levels to tumor tissue laboratory assays (RNA seq and proteomics) of glutamine/glutamate, glucose, and lactate metabolism.
View original scientific description
* To perform metabolic phenotyping of treatment naïve and recurrent GBM by multitracer \[18F\]Fluciclovine and 18F-FDG PET. * To compare uptake measures of 18F-Fluciclovine and 18F-FDG and MRI quantification of glutamate and lactate levels to tumor tissue laboratory assays (RNA seq and proteomics) of glutamine/glutamate, glucose, and lactate metabolism.
Interventions
DRUG
Fluciclovine F18
To perform metabolic phenotyping of treatment naïve and recurrent GBM by multitracer \[18F\]Fluciclovine and 18F-FDG PET.
Primary outcome measures
Uptake Values (SUV)
Time frame: 2 years
Quantification of \[18F\]Fluciclovine and 18F-FDG uptake values (SUV) in treatment naïve and recurrent GBM.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants will be ≥ 18 years of age Must meet the following criteria: -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 (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 criteria
- 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
Where
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 28, 2025 · Source of record for eligibility and locations