Recruiting
Early Phase 1

Metabolic Profiling

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT06613841

Conditions

Glioblastoma

Recurrent Glioblastoma

Glioblastoma Multiforme of Brain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fluciclovine F18

Study Details

Brief 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

Conditions

Glioblastoma

Recurrent Glioblastoma

Glioblastoma Multiforme of Brain

Study ID

NCT06613841

Start date

May 1, 2025

Status verified date

May, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Fluciclovine F18

To perform metabolic phenotyping of treatment naïve and recurrent GBM by multitracer \[18F\]Fluciclovine and 18F-FDG PET.

Primary outcome measure

  • Uptake Values (SUV) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Leeanne Lezotte

8563643137leeanne.lezotte@pennmedicine.upenn.edu

Jeremy T Westerman, B.S.

2159199110jeremy.westerman@pennmedicine.upenn.edu

Locations

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Jeremy T Westerman, B.S. Biology

2159199110Jeremy.Westerman@pennmedicine.upenn.edu

Leeanne Lezotte

8563643137leeanne.lezotte@pennmedicine.upenn.edu

Principal Investigator:

Ali Nabavizadeh, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Leeanne Lezotte

8563643137leeanne.lezotte@pennmedicine.upenn.edu

Jeremy T Westerman, B.S.

2159199110jeremy.westerman@pennmedicine.upenn.edu

Principal Investigator:

Ali Nabavizadeh, MD

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Nov 28, 2025

Last verified

May, 2025

Keywords

  • Early Phase 1
  • Cohort
  • Glioblastoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2025-11-28.