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

NCT06613841 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: UPCC15324
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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

Keywords

Early Phase 1; Cohort; Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Uptake Values (SUV)

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

  2 years

Other Outcomes (2)

• PET uptake values relation to kinetic parameters

  2 years

• Quantification of glutamate and lactate levels

  2 years

Study Arms (1)

Imaging Cohort

EXPERIMENTAL

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.

Drug: Fluciclovine F18

Interventions

Fluciclovine F18 DRUG

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

Imaging Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (1)

• Nabavizadeh A, Bagley SJ, Doot RK, Ware JB, Young AJ, Ghodasara S, Zhao C, Anderson H, Schubert E, Carpenter EL, Till J, Henderson F Jr, Pantel AR, Chen HI, Lee JYK, Amankulor NM, O'Rourke DM, Desai A, Nasrallah MP, Brem S. Distinguishing Progression from Pseudoprogression in Glioblastoma Using 18F-Fluciclovine PET. J Nucl Med. 2023 Jun;64(6):852-858. doi: 10.2967/jnumed.122.264812. Epub 2022 Dec 22.

  PMID: 36549916 RESULT

MeSH Terms

Conditions

Glioblastoma

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Ali Nabavizadeh, MD

  University of Pensylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leeanne Lezotte

CONTACT

8563643137; leeanne.lezotte@pennmedicine.upenn.edu

Jeremy T Westerman, B.S.

CONTACT

2159199110; jeremy.westerman@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 26, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-05

Locations

US (2)