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

ConditionsGlioblastomaRecurrent GlioblastomaGlioblastoma Multiforme of Brain
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine

About this trial

* 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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Fluciclovine F18

    Drug

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

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Imaging CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Uptake Values (SUV)

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

Time frame
2 years

Secondary outcomes

Other outcomes

1

PET uptake values relation to kinetic parameters

Correlation of PET uptake values (SUV) and kinetic parameters (volume of distribution) with gene expression of glutamine and glucose metabolism.

Time frame
2 years
2

Quantification of glutamate and lactate levels

The amount of metabolic markers (e.g., glutamate, 5 to 15 mM in normal brain tissue) using 7T MRI. Tumors with high glutamate secretion are associated with increased tumor cell invasiveness.

Time frame
2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abramson Cancer Center at Penn Medicine

Lead sponsor

University of Pennsylvania

Sponsor institution

Source ClinicalTrials.gov
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