Contact information
Type
Scientific
Primary contact
Dr Kumar Das
ORCID ID
Contact details
Radiology Department
The Walton Centre NHS Foundation Trust
Fazakerley
Liverpool
L9 7LJ
United Kingdom
+44 (0)151 529 5538
kumar.das@thewaltoncentre.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Detection of pseudoprogression using CT perfusion in patients with Glioblastoma Multiforme post-treatment: an observational cohort study
Acronym
Study hypothesis
This study will use CT perfusion scans to look for changes in the brain following treatment for a brain tumour. It is often difficult to detect changes in the brain that are caused as a result of the treatment effects, for example residual damage following radiosurgery may initially look like the tumour has progressed. Using CT perfusion techniques, additional physiological information relating to the tumour site can be acquired which will assist in the correct treatment management of the patient. It should be noted however that patients do not at present have a CT perfusion examination to assist in monitoring the progress of their tumour surveillance over their course of the patient's treatment, therefore this study would require additional ionising radiation, as the patients are only monitored using MRI perfusion techiques at this time.
Ethics approval
North West - Haydock Research Ethics Committee, 01/06/2015, ref: 15/NW/0399
Study design
Prospective observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
See additional files
Condition
Glioblastoma Multiforme
Intervention
A single CT perfusion scan will be carried out during the study. The study will be prospective and each patient will follow the procedure below:
Newly diagnosed patients with glioblastoma multiforme tumour will be given a neurosurgical referral, and then offered a course of treatment, depending on the classification of the tumour that will be either, or a combination of chemotherapy, radiosurgery or neurosurgery. After 3 months of treatment, the patient will undergo post-operative MRI. If the MRI scan shows no progression, the normal protocols will be followed. If the MRI scan shows tumour progression, they will have their case discussed at a multi-disciplinary team meeting (comprising neurosurgeons, neurologists, neuroradiologists and oncology nursing staff). If there is clinical progression (symptoms are reported to be present or worsening) present, an MRI perfusion scan will be performed and the clinical team will decide on further treatment management, which could include more surgery, radiotherapy or chemotherapy. If no clinical progression has been identified, the patient will undergo CT perfusion and MR perfusion on the same day, and be discharged. The CT and MRI perfusion scans will be reviewed and used for further management/monitoring. At 8 weeks post-treatment, if there is no clinical progression and no tumour progression on the scans, pseudoprogression of the tumour is likely. If after 8 weeks, there has been clinical symptom progression and this is seen on the scans, the patient will be followed up 8 weeks later. Incidence rate and frequency will be calculated using Two-tailed student t-test and ROC curve for analysis of sensitivity and specificity. Potential benefits include the timely and more accurate detection of pseudoprogression in this patient group, allowing changes relating to their treatment to be tailored accordingly. The sensitivity and specificity of CT perfusion in the differentiation between true tumour progression and pseudoprogression.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Diagnosis of true tumour progression measured by MRI scan 8 weeks after treatment
Secondary outcome measures
Better diagnosis and improved treatment options
Overall trial start date
01/03/2015
Overall trial end date
01/03/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with glioblastoma multiforme tumours who will be discussed in the regional neuro-oncology multidisciplinary team meeting
2. Patients exhibiting any tumour progression on their first follow-up imaging immediately after radiotherapy, surgery or chemotherapy post-treatment without clinical progression
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
Patients who exhibit tumour progression both clinically (symptoms) and on imaging on the first follow-up imaging immediately following radiotherapy, chemotherapy or surgery following treatment
Recruitment start date
01/05/2015
Recruitment end date
01/05/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Walton Centre NHS Foundation Trust
Lower Lane
Fazakerley
Liverpool
L9 7LJ
United Kingdom
Sponsor information
Organisation
The Walton Centre NHS Foundation Trust
Sponsor details
Research and Development and Innovation Department
Liverpool
L9 7LJ
United Kingdom
+44 (0)151 529 8854
dave.watling@thewaltoncentre.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
The Walton Centre NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We intend to dissemination the results hopefully by 2017 to all revalant parties but do not have any plans to publish as yet.
Intention to publish date
31/12/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN68166254_PIS_V1.2.docx Uploaded 09/05/2016