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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 99 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02902757
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Jonsson Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Johannes Czernin, MD
Principal Investigator Affiliation UCLA / Jonsson Comprehensive Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

Procedure: - Computed Tomography

Undergo FDG PET/CT

Radiation: - Fludeoxyglucose F-18

Undergo FDG PET/CT

Procedure: - Positron Emission Tomography

Undergo FDG PET/CT

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Recruiting

Address

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095

Site Contact

Soosan Roodbari

sroodbari@mednet.ucla.edu

310-794-1596