NCT06613841 Multitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI for Metabolic Profiling of Glioblastoma
| NCT ID | NCT06613841 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Abramson Cancer Center at Penn Medicine |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2025-05-01 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Ali Nabavizadeh, MD
PRINCIPAL INVESTIGATOR
University of Pensylvania
Frequently Asked Questions
Who can join the NCT06613841 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06613841 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06613841 currently recruiting?
Yes, NCT06613841 is actively recruiting participants. Contact the research team at leeanne.lezotte@pennmedicine.upenn.edu for enrollment information.
Where is the NCT06613841 trial being conducted?
This trial is being conducted at Philadelphia, United States, Philadelphia, United States.
Who is sponsoring the NCT06613841 clinical trial?
NCT06613841 is sponsored by Abramson Cancer Center at Penn Medicine. The principal investigator is Ali Nabavizadeh, MD at University of Pensylvania. The trial plans to enroll 15 participants.
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