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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 48 hours for reporting.

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 • NCT00062374

65%

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

Thrombosis

Alopecia

Hypernatremia

Weight loss

Hearing impaired

Constipation

Dyspepsia

Mood alteration/anxiety

Taste disturbance

Febrile neutropenia

Dysphagia

Pain, other

Hypoglycemia

Pharyngeal mucositis

Hemorrhage, NOS

CNS/cerebrovascular ischemia

Chest pain

Seizure

Cardiovascular, other

Muscle weakness

Gastrointestinal disorder

Hypotension

Creatinine increased

100%

80%

60%

40%

20%

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

~2790