NCT02902757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

9.4 years

First QC Date

September 12, 2016

Last Update Submit

December 15, 2025

Conditions

Keywords

FDGPET/CT very early response (48 hrs)

Outcome Measures

Primary Outcomes (2)

  • 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.

    From baseline up to 48 hours

  • 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.

    One PET/CT 48 hours after start of therapy

Study Arms (1)

Treatment (FDG PET/CT)

EXPERIMENTAL

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 TomographyRadiation: Fludeoxyglucose F-18Procedure: Positron Emission Tomography

Interventions

Undergo FDG PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography
Treatment (FDG PET/CT)

Undergo FDG PET/CT

Also known as: 18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Treatment (FDG PET/CT)

Undergo FDG PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Treatment (FDG PET/CT)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically proven high grade glioma
  • Intention to start therapy

You may not qualify if:

  • Severe psychiatric illness
  • Inability to give written consent
  • Breast feeding / pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Fluorodeoxyglucose F18Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydratesSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Johannes Czernin, MD

    UCLA / Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 16, 2016

Study Start

August 25, 2015

Primary Completion

January 29, 2025

Study Completion

January 29, 2025

Last Updated

December 17, 2025

Record last verified: 2025-12

Locations