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

Primary Purpose

Glioblastoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Fludeoxyglucose F-18
Positron Emission Tomography
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioblastoma focused on measuring FDG, PET/CT very early response (48 hrs)

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA / Jonsson Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (FDG PET/CT)

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes in glucose uptake
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.
Very early changes in tumor glucose uptake predictive for objective treatments response and survival assessed using RANO criteria
SUV will be calculated for different organs and for regions of tumor. Further, regional target to background count-activity ratios will be established.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2016
Last Updated
December 1, 2022
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02902757
Brief Title
FDG PET/CT in Monitoring Very Early Therapy Response in Patients With Glioblastoma
Official Title
Very Early Response Monitoring in Patients With Glioblastoma Undergoing Therapy Using FDG PET/CT
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2015 (Actual)
Primary Completion Date
August 25, 2023 (Anticipated)
Study Completion Date
August 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
PRIMARY OBJECTIVES: I. To assess very early response to therapy in glioblastoma patients using 18F-FDG PET/CT. II. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
FDG, PET/CT very early response (48 hrs)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (FDG PET/CT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography
Intervention Description
Undergo FDG PET/CT
Intervention Type
Radiation
Intervention Name(s)
Fludeoxyglucose F-18
Other Intervention Name(s)
18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Intervention Description
Undergo FDG PET/CT
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo FDG PET/CT
Primary Outcome Measure Information:
Title
Changes in glucose uptake
Description
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.
Time Frame
From baseline up to 48 hours
Title
Very early changes in tumor glucose uptake predictive for objective treatments response and survival assessed using RANO criteria
Description
SUV will be calculated for different organs and for regions of tumor. Further, regional target to background count-activity ratios will be established.
Time Frame
One PET/CT 48 hours after start of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soosan Roodbari
Phone
310 794-1596
Email
sroodbari@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Czernin, MD
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soosan Roodbari
Phone
310-794-1596
Email
sroodbari@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Johannes Czernin, MD

12. IPD Sharing Statement

Learn more about this trial

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

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