RECRUITING

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

Conditions

Glioblastoma Recurrent Glioblastoma Glioblastoma Multiforme of Brain Early Phase 1 Cohort

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2025-05-01

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06613841

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participants will be ≥ 18 years of age * 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.	* 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

Inclusion Criteria

Exclusion Criteria

* Participants will be ≥ 18 years of age
* 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.

* 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

Contacts and Locations

Study Contact

Leeanne Lezotte

CONTACT

8563643137

leeanne.lezotte@pennmedicine.upenn.edu

Jeremy T Westerman, B.S.

CONTACT

2159199110

jeremy.westerman@pennmedicine.upenn.edu

Principal Investigator

Ali Nabavizadeh, MD

PRINCIPAL_INVESTIGATOR

University of Pensylvania

Study Locations (Sites)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

Ali Nabavizadeh, MD, PRINCIPAL_INVESTIGATOR, University of Pensylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-05-01

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Early Phase 1
Cohort
Glioblastoma

Additional Relevant MeSH Terms

Glioblastoma
Recurrent Glioblastoma
Glioblastoma Multiforme of Brain