Metabolic profiling of glioblastoma using advanced imaging techniques
Pilot Study to Evaluate Multitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI Methods at 7Tesla Metabolic Profiling of Glioblastoma
EARLY_PHASE1 · Abramson Cancer Center at Penn Medicine · NCT06613841
This study is testing new imaging techniques to see how glioblastoma tumors use energy and nutrients, which could help doctors understand the tumors better and improve treatment options.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine (other) |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT06613841 on ClinicalTrials.gov |
What this trial studies
This study aims to perform metabolic phenotyping of treatment-naïve and recurrent glioblastoma (GBM) using multitracer PET imaging with 18F-Fluciclovine and 18F-FDG, along with advanced MRI techniques. Participants will undergo dynamic PET/CT scans to evaluate the uptake of these tracers and will also have the option for additional MRI scans to assess glutamate and lactate levels. The goal is to compare imaging results with tumor tissue assays to better understand metabolic processes in GBM. This research could provide insights into tumor behavior and treatment responses.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of glioblastoma or recurrent glioblastoma who are recommended for surgical resection.
Not a fit: Patients who are unable to tolerate imaging procedures or have a life expectancy of less than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment strategies for patients with glioblastoma.
How similar studies have performed: Other studies utilizing advanced imaging techniques for metabolic profiling in glioblastoma have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Philadelphia, Pennsylvania and 1 other locations
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Ali Nabavizadeh, MD — University of Pensylvania
- Study coordinator: Leeanne Lezotte
- Email: leeanne.lezotte@pennmedicine.upenn.edu
- Phone: 8563643137
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glioblastoma, Recurrent Glioblastoma, Glioblastoma Multiforme of Brain, Early Phase 1, Cohort