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FDG PET/CT Scan for Glioblastoma
N/A
Recruiting
Led By Johannes Czernin, MD
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with histologically proven high grade glioma
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 48 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial will study whether FDG PET/CT can help measure early therapy response in patients with glioblastoma.
Who is the study for?
This trial is for patients with high-grade glioma, specifically glioblastoma, who are about to start therapy. They must be able to provide written consent and not have severe psychiatric illnesses. Pregnant or breastfeeding individuals cannot participate.
What is being tested?
The study is testing the use of FDG PET/CT scans in detecting early responses to treatment in glioblastoma patients. It aims to see if changes in tumor glucose consumption after starting chemotherapy can indicate how well the treatment is working.
What are the potential side effects?
Since this trial involves diagnostic procedures rather than drugs, side effects may include discomfort from the PET/CT scan process and exposure to radiation during imaging.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a high-grade brain tumor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 48 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in glucose uptake
Very early changes in tumor glucose uptake predictive for objective treatments response and survival assessed using RANO criteria
Side effects data
From 2011 Phase 2 trial • 55 Patients • NCT0006237465%
Fatigue
64%
Hypocalcemia
60%
Nausea
58%
White blood cell count decrease
56%
Neutrophil count decrease
55%
Hemoglobin decrease
45%
Diarrhea
38%
Platelet count decreased
36%
Hyponatremia
31%
Hypophosphatemia
29%
Hypokalemia
29%
Anorexia
27%
Abdominal pain/cramping
22%
Hypomagnesemia
22%
Vomiting
20%
Hyperglycemia
20%
Hyperkalemia
20%
Lymphocyte count decrease
20%
Neuropathy-sensory
20%
Hypoalbuminemia
18%
Alanine aminotransferase increase
13%
Dyspnea
13%
Aspartate aminotransferase increase
11%
Dehydration
11%
Creatinine
11%
Dizziness
11%
Edema
9%
Thrombosis
9%
Alopecia
9%
Hypernatremia
9%
Weight loss
7%
Hearing impaired
7%
Constipation
7%
Dyspepsia
7%
Mood alteration/anxiety
7%
Taste disturbance
5%
Febrile neutropenia
5%
Dysphagia
5%
Pain, other
5%
Hypoglycemia
5%
Pharyngeal mucositis
4%
Hemorrhage, NOS
4%
CNS/cerebrovascular ischemia
4%
Chest pain
2%
Seizure
2%
Cardiovascular, other
2%
Muscle weakness
2%
Gastrointestinal disorder
2%
Hypotension
2%
Creatinine increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (FDG PET/CT)Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2011
Completed Phase 2
~2200
Computed Tomography
2017
Completed Phase 2
~2740
Fludeoxyglucose F-18
2018
Completed Phase 4
~610
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
370 Previous Clinical Trials
35,144 Total Patients Enrolled
18 Trials studying Glioblastoma
500 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,927 Previous Clinical Trials
41,017,955 Total Patients Enrolled
330 Trials studying Glioblastoma
23,326 Patients Enrolled for Glioblastoma
National Institutes of Health (NIH)NIH
2,816 Previous Clinical Trials
8,161,689 Total Patients Enrolled
12 Trials studying Glioblastoma
597 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I plan to begin treatment.I have been diagnosed with a high-grade brain tumor.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (FDG PET/CT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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