Detection of pseudoprogression using CT perfusion in patients with Glioblastoma Multiforme post-treatment

ISRCTN	ISRCTN68166254
DOI	https://doi.org/10.1186/ISRCTN68166254
Secondary identifying numbers	N/A

Submission date: 20/04/2015
Registration date: 01/07/2015
Last edited: 06/06/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-using-a-ct-scan-to-detect-false-growth-in-brain-tumours-after-treatment-ctpip

Contact information

Dr Kumar Das
Scientific

Radiology Department
The Walton Centre NHS Foundation Trust
Fazakerley
Liverpool
L9 7LJ
United Kingdom

Phone	+44 (0)151 529 5538
Email	kumar.das@thewaltoncentre.nhs.uk

Study information

Study design	Prospective observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	ISRCTN68166254_PIS_V1.2.docx
Scientific title	Detection of pseudoprogression using CT perfusion in patients with Glioblastoma Multiforme post-treatment: an observational cohort study
Study objectives	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(s)	North West - Haydock Research Ethics Committee, 01/06/2015, ref: 15/NW/0399
Health condition(s) or problem(s) studied	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
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 study start date	01/03/2015
Completion date	01/03/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	20
Key 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
Key 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
Date of first enrolment	01/05/2015
Date of final enrolment	01/05/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The Walton Centre NHS Foundation Trust

Lower Lane
Fazakerley
Liverpool
L9 7LJ
United Kingdom

Sponsor information

The Walton Centre NHS Foundation Trust
Hospital/treatment centre

Research and Development and Innovation Department
Liverpool
L9 7LJ
England
United Kingdom

Phone	+44 (0)151 529 8854
Email	dave.watling@thewaltoncentre.nhs.uk
"ROR"	https://ror.org/05cvxat96

Funders

Funder type

Government

The Walton Centre NHS Foundation Trust (UK)

No information available

Results and Publications

Intention to publish date	31/12/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version V1.2		09/05/2016	No	Yes
HRA research summary			28/06/2023	No	No

Additional files

ISRCTN68166254_PIS_V1.2.docx: Uploaded 09/05/2016

Editorial Notes

06/06/2018: No publications found, verifying study status with principal investigator.
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.