NCT01923922

Brief Summary

High grade cerebral glioma is the most common primary brain tumor in adults and accounts for about 2.5% of all cancer deaths. Brain tumor affects approximately 2300 individuals per year in Canada. Noninvasive accurate and timely diagnosis is imperative. High grade glioma is an aggressive neoplasm with median survival of 12 months, irrespective of any treatment. The prognosis of these patients can only be decided based on pathology after biopsy or surgery. Conventional imaging techniques, such as routine magnetic resonance imaging(MRI), do not accurately predict the grade of malignancy of cerebral gliomas. Computed tomography(CT) perfusion allows us to study the blood supply to the tumor at the level of capillaries. This information permits determination of aggressiveness of cerebral gliomas at the time of diagnosis. In a preliminary study of 20 patients with high grade cerebral gliomas, we have shown that CT perfusion can predict survival at the time of diagnosis irrespective of the pathological grade and the treatment received. In the present study, we would like to extend our preliminary findings in larger group of patients to ensure that this technique is indeed robust. If our hypothesis was supported by our study, we will be able to subselect patients based on initial imaging for more aggressive treatment. In patients with shorter survival, the perfusion parameters may help in identifying new therapeutic targets (e.g., anti-angiogenic agents) that may help in the treatment of these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

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

First Submitted

Initial submission to the registry

August 9, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2013

Completed
24 days until next milestone

Study Start

First participant enrolled

September 9, 2013

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2019

Completed
Last Updated

August 21, 2024

Status Verified

October 1, 2022

Enrollment Period

6.1 years

First QC Date

August 9, 2013

Last Update Submit

August 19, 2024

Conditions

Keywords

glioblastoma multiformeCT PerfusionSurvival

Outcome Measures

Primary Outcomes (1)

  • Survival of patients with high grade cerebral glioma based on the CT perfusion parameters irrespective of the pathological grade and irrespective of the treatment given.

    1 year

Secondary Outcomes (1)

  • Number of Adverse Events as a Measure of Safety and Tolerability

    30 day

Study Arms (1)

CT Perfusion

OTHER

Participants with suspected Glioblastoma Multiforme undergo CT perfusion prior to surgery or biopsy.

Radiation: CT Perfusion

Interventions

CT PerfusionRADIATION

The CT perfusion scan will be performed on a multi-detector CT scanner at the time of routine preoperative neuronavigation imaging. A non-contrast CT head scan will be acquired to localize the tumour. Four 5 mm thick slices will be selected at the level of the tumour. Multiple images will be acquired at each levels starting 5 sec after the injection of 50 cc of non-ionic iodinated contrast media at a rate of 4 cc/sec. The acquisition parameters will be 80 kVp and 100 mA. The images will be acquired every second for a total of 110 sec. The post- processing will be performed and parameters will be calculated using regions of interest in the areas of tumour showing the highest perfusion values. Another region of interest will be placed in the contralateral normal looking white matter.

CT Perfusion

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients, presenting with a newly detected brain lesion likely to be high grade cerebral glioma either on CT or MRI of the brain

You may not qualify if:

  • Pregnant patients
  • those with impaired renal function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QE II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Related Publications (1)

  • Shankar JJ, Woulfe J, Silva VD, Nguyen TB. Evaluation of perfusion CT in grading and prognostication of high-grade gliomas at diagnosis: a pilot study. AJR Am J Roentgenol. 2013 May;200(5):W504-9. doi: 10.2214/AJR.12.8967.

    PMID: 23617517BACKGROUND

MeSH Terms

Conditions

Glioblastoma

Interventions

Cytidine Triphosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Jai Shankar

    Capital District Health Auhtority

    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

August 9, 2013

First Posted

August 16, 2013

Study Start

September 9, 2013

Primary Completion

October 22, 2019

Study Completion

October 22, 2019

Last Updated

August 21, 2024

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations