Detection of pseudoprogression using CT perfusion in patients with Glioblastoma Multiforme post-treatment
| ISRCTN | ISRCTN68166254 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68166254 |
| Protocol serial number | N/A |
| Sponsor | The Walton Centre NHS Foundation Trust |
| Funder | The Walton Centre NHS Foundation Trust (UK) |
- 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
Contact information
Dr Kumar Das
Scientific
Scientific
Radiology Department
The Walton Centre NHS Foundation Trust
Fazakerley
Liverpool
L9 7LJ
United Kingdom
| Phone | +44 (0)151 529 5538 |
|---|---|
| kumar.das@thewaltoncentre.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational cohort study |
| Secondary study design | Cohort study |
| 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(s) | Diagnosis of true tumour progression measured by MRI scan 8 weeks after treatment |
| Key secondary outcome measure(s) | Better diagnosis and improved treatment options |
| Completion date | 01/03/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
The Walton Centre NHS Foundation Trust
Lower Lane
Fazakerley
Liverpool
L9 7LJ
United Kingdom
Fazakerley
Liverpool
L9 7LJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version V1.2 | 09/05/2016 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
