Clincosm LogoSign in Get a demo

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

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Terminated
CT.gov ID
NCT03573986
Collaborator
(none)
2
Enrollment
1
Location
1
Arm
20.9
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: [18F]fluoromisonidazole
  • Drug: Bevacizumab
  • Radiation: positron emission tomography (PET/CT).
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
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
Actual Study Start Date :
Apr 18, 2018
Actual Primary Completion Date :
Jan 14, 2020
Actual Study Completion Date :
Jan 14, 2020

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Number of Adverse Events [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • Abramson Cancer Center of the University of Pennsylvania

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abramson Cancer Center of the University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT03573986
    Other Study ID Numbers:
    • UPCC 02318
    First Posted:
    Jun 29, 2018
    Last Update Posted:
    Feb 17, 2020
    Last Verified:
    Feb 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Glioblastoma
    Recurrence
    Hypoxia
    Bevacizumab

    Study Results

    No Results Posted as of Feb 17, 2020