Condition category
Cancer
Date applied
20/04/2015
Date assigned
01/07/2015
Last edited
09/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Please 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 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

01/03/2015

Overall trial end date

01/03/2016

Reason abandoned

Eligibility

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

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

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.