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New treatment option for Glioblastoma
Official title Multitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI for Metabolic Profiling of Glioblastoma
ClinicalTrials.gov ID: NCT06613841
What this study is testing
What is Fluciclovine F18?
Fluciclovine F18 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for glioblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- New contrast-enhancing lesion or lesions showing increased enhancement (\>25%increase) in a patient with a historical diagnosis of glioblastoma...
- 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
You likely can't join 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...
- Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician...
- Contraindications to MRI
- Only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study
See the full eligibility 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...
- 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...
- 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...
- Contraindications to MRI
- Only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.