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FDG PET/CT in Monitoring Very Early Therapy Response in Patients With Glioblastoma

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02902757
Collaborator
National Cancer Institute (NCI) (NIH), National Institutes of Health (NIH) (NIH)
50
Enrollment
1
Location
1
Arm
96
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This pilot clinical trial studies fluordeoxyglucose (fludeoxyglucose) F-18 (FDG) positron emission tomography (PET)/computed tomography (CT) in monitoring very early therapy response in patients with glioblastoma. Diagnostic procedures, such as FDG PET/CT, may help measure a patient's response to earlier treatment. Chemotherapy can induce very rapid changes to the tumor's glucose consumption which can be measured with imaging. FDG PET/CT shortly after the start of therapy may help identify very early therapy response in patients with glioblastoma.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Computed Tomography
  • Radiation: Fludeoxyglucose F-18
  • Procedure: Positron Emission Tomography
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. To assess very early response to therapy in glioblastoma patients using 18F-FDG PET/CT.

  2. Evaluate very early changes in FDG uptake within 48 hours of start of therapy and correlate them with objective response parameters such as Response Assessment in Neuro-Oncology (RANO) and survival.

OUTLINE:

Patients undergo standard FDG PET/CT scan 6-8 weeks before start of chemotherapy and one additional FDG PET/CT scan within 48 hours of the start of chemotherapy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Very Early Response Monitoring in Patients With Glioblastoma Undergoing Therapy Using FDG PET/CT
Actual Study Start Date :
Aug 25, 2015
Anticipated Primary Completion Date :
Aug 25, 2022
Anticipated Study Completion Date :
Aug 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (FDG PET/CT)

Patients undergo standard FDG PET/CT scan 6-8 weeks before start of chemotherapy and one additional FDG PET/CT scan within 48 hours of the start of chemotherapy.

Procedure: Computed Tomography
Undergo FDG PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography

    • Radiation: Fludeoxyglucose F-18
    Undergo FDG PET/CT
    Other Names:
  • 18FDG
  • FDG
  • fludeoxyglucose F 18
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18

    • Procedure: Positron Emission Tomography
    Undergo FDG PET/CT
    Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in glucose uptake [From baseline up to 48 hours]

      Standardized uptake values (SUV) will be calculated for different organs and for regions of tumor. Further, regional target to background count-activity ratios will be established.

    2. Very early changes in tumor glucose uptake predictive for objective treatments response and survival assessed using RANO criteria [One PET/CT 48 hours after start of therapy]

      SUV will be calculated for different organs and for regions of tumor. Further, regional target to background count-activity ratios will be established.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with histologically proven high grade glioma

    • Intention to start therapy

    Exclusion Criteria:

    • Severe psychiatric illness

    • Inability to give written consent

    • Breast feeding / pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA / Jonsson Comprehensive Cancer Center Los Angeles California United States 90095

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center
    • National Cancer Institute (NCI)
    • National Institutes of Health (NIH)

    Investigators

    • Principal Investigator: Johannes Czernin, MD, UCLA / Jonsson Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonsson Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02902757
    Other Study ID Numbers:
    • 15-000409
    • NCI-2016-00583
    • 15-000409
    First Posted:
    Sep 16, 2016
    Last Update Posted:
    Feb 4, 2022
    Last Verified:
    Feb 1, 2022
    Keywords provided by Jonsson Comprehensive Cancer Center
    FDG
    PET/CT very early response (48 hrs)
    Additional relevant MeSH terms:
    Glioblastoma
    Deoxyglucose
    Fluorodeoxyglucose F18

    Study Results

    No Results Posted as of Feb 4, 2022