Pilot Study of 18F-FMISO PET/CT and MRI Imaging to Explore Tissue Hypoxia and Arteriovenous Shunting in Subjects With Recurrent Glioblastoma Before and After Bevacizumab Treatment

Subjects with recurrent glioblastoma who are candidates for bevacizumab treatment according to standard of care will be eligible for this study. Positron emission tomography (PET/CT) imaging will use the investigational radiotracer [18F]FMISO to image the brain and evaluate for hypoxia pre and post therapy.. Subjects will also undergo up to three Brain MRIs.

Study Overview

• Status: Terminated
• Conditions: Recurrent Glioblastoma
• Intervention / Treatment: Biological: [18F]fluoromisonidazole; Drug: Bevacizumab; Radiation: positron emission tomography (PET/CT).

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of The University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants will be ≥ 18 years of age
• Biopsy proven glioblastoma
• Must meet one of the following criteria:
• Recent surgery (within 2 months) showing recurrent glioblastoma with measurable (20 mm in 2 dimensions) residual tumor.

Radiologic evidence of recurrent tumor based on conventional and advanced MRI findings.

• Recommended for clinically indicated bevacizumab therapy
• 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
• Less than 3 months from finishing the most recent radiation or immunotherapy.
• Contraindications to MRI or use of gadolinium contrast
• Only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must understand and be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care. This should negate any undue influence or coercion. Pregnant women, children, fetuses, neonates, or prisoners are not included in this research study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Arm A

Biological: [18F]fluoromisonidazole; positron emitting radiopharmaceutical that has been studied in vivo in humans for measurement of regional hypoxia in a number of tumor types with positron emission tomography (PET/CT); Other Names: 18F-FMISO; Drug: Bevacizumab; Bevacizumab (Avastin, Genentech/Roche) is a humanized monoclonal antibody that binds to VEGF preventing its interaction with VEGFRs resulting in suppression of VEGF signaling.; Radiation: positron emission tomography (PET/CT).; PET-CT Scan 1.) before start of Bevacizumab up to approximately 4 weeks and 2.) within 12-22 days of start of Bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Adverse Events	2 years

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Investigators: Principal Investigator: Seyed Ali Nabavizadeh, MD, Abramson Cancer Center of The University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2018
• Primary Completion (ACTUAL): January 14, 2020
• Study Completion (ACTUAL): January 14, 2020

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (ACTUAL): June 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Signs and Symptoms, Respiratory; Glioblastoma; Recurrence; Hypoxia; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: UPCC 02318

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No