18F-Fluciclovine, PET / CT and MRI, and cfDNA in Differentiating Tumor Progression in Patients with Glioblastoma

Status: Active

Description

This phase I trial studies how well 18F-fluciclovine positron emission tomography (PET) / computed tomography (CT) and magnetic resonance imaging (MRI) scans and circulating cell-free deoxyribonucleic acid (cfDNA) work in differentiating tumor progression in patients with glioblastoma. 18F-fluciclovine is a radioactive tracer used to image areas where doctors think the tumor has come back or if there is a change in the area because of previous treatment. PET / CT and MRI scans are types of imaging that can track where 18F-fluciclovine is taken up in the body. cfDNA is a type of substance that is shed by a tumor into the bloodstream and may provide useful information about the tumor. Giving 18F-fluciclovine PET / CT and MRI scans and studying cfDNA may help doctors better understand tumor growth and disease progression in patients with glioblastoma.

Eligibility Criteria

Inclusion Criteria

  • Initial diagnosis of glioblastoma (histologic or molecular proof)
  • Completion of chemoradiation
  • New contrast-enhancing lesions or lesions showing increased enhancement (> 25% increase) on standard MRI after completion of chemoradiation
  • Recommended for clinical surgical resection
  • Life expectancy of greater than 3 months in the opinion of an investigator or treating physician
  • Karnofsky performance status >= 60
  • 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 breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening
  • 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 or use of gadolinium contrast

Locations & Contacts

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Contact: Seyed Ali Nabavizadeh
Phone: 215-662-6865
Email: SeyedAli.Nabavizadeh@uphs.upenn.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To compare fluciclovine F18 (18F-fluciclovine) PET uptake measures in glioblastoma patients with tumor progression versus (vs) pseudoprogression.

SECONDARY OBJECTIVES:

I. To determine a multidimensional signature using 18F-fluciclovine PET, MRI, and plasma cfDNA that accurately differentiates tumor progression from pseudoprogression in post-chemoradiation glioblastoma (GBM).

OUTLINE:

Patients receive fluciclovine F18 intravenously (IV). Patients then undergo a PET/CT scan over 60 minutes, a brain MRI scan over 60 minutes, and collection of blood within one week prior to surgery.

After completion of study, patients are followed up periodically.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Diagnostic

Lead Organization

Lead Organization
University of Pennsylvania / Abramson Cancer Center

Principal Investigator
Seyed Ali Nabavizadeh

Trial IDs

Primary ID UPCC 08319
Secondary IDs NCI-2019-04557
Clinicaltrials.gov ID NCT03990285