Pilot Study to Evaluate Multitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI Methods at 7Tesla Metabolic Profiling of Glioblastoma

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

* 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. * To perform metabolic phenotyping of treatment naïve and recurrent GBM by advanced MRI methods at 7 Tesla

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Leeanne Lezotte
leeanne.lezotte@pennmedicine.upenn.edu
8563643137
Backup
Jeremy T Westerman, B.S.
jeremy.westerman@pennmedicine.upenn.edu
2159199110
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 15
Treatments
Experimental: Imaging Cohort
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.
Sponsors
Leads: Abramson Cancer Center at Penn Medicine

This content was sourced from clinicaltrials.gov