Search / Trial NCT06613841

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

Launched by ABRAMSON CANCER CENTER AT PENN MEDICINE · Sep 23, 2024

Trial Information

Current as of October 04, 2024

Not yet recruiting

Keywords

Early Phase 1 Cohort Glioblastoma

Description

Subjects with a new intra-axial brain mass that is consistent with glioblastoma (GBM) on brain MRI or post-treatment histologically or molecularly proven GBM who are suspected to have progression and are candidates for surgical resection according to standard of care may be eligible for this study. Subjects will undergo approximately 45 minutes of dynamic PET/CT scanning after injection of 2 mCi (±20%) of 18F-Fluciclovine. The subject will have a 60-minute break after this initial scan session, they will be allowed to get off the scanner during this time and encouraged to stay hydrated and...

Gender

ALL

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

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Philadelphia, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0