Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Dr Kumar Das


Contact details

Radiology Department
The Walton Centre NHS Foundation Trust
L9 7LJ
United Kingdom
+44 (0)151 529 5538

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Detection of pseudoprogression using CT perfusion in patients with Glioblastoma Multiforme post-treatment: an observational cohort study


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


Secondary study design

Cohort study

Trial setting


Trial type


Patient information sheet

Please see additional files


Glioblastoma Multiforme


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



Drug names

Primary outcome measures

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


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Patients with glioblastoma multiforme tumours who will be discussed in the regional neuro-oncology multi-disciplinary 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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

The Walton Centre NHS Foundation Trust
Lower Lane Fazakerley
L9 7LJ
United Kingdom

Sponsor information


The Walton Centre NHS Foundation Trust

Sponsor details

Research and Development and Innovation Department
L9 7LJ
United Kingdom
+44 (0)151 529 8854

Sponsor type

Hospital/treatment centre



Funder type


Funder name

The Walton Centre NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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


Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

09/05/2016: The participant information sheet has been uploaded. 30/03/2016: Ethics approval information added. 20/01/2016: Link added to Plain English summary field.