The main objective of the study is to compare the diagnostic power of Magnetic Resonance Spectroscopy, Fluorothymidine Positron Emission Tomography and conventional MRI in measuring the response of glioblastoma to radiotherapy and chemotherapy.The…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patients will be followed during the standard treatment.
Before the neurosurgical operation, before and after the radiotherapy with
concomitant chemotherapy, before the additive chemotherapy and after 2, 4 and 6
cycles of chemotherapy a MRI, MRS and FLT-PET scan will be made.
The operation, radiotherapy and chemotherapy will not be postponed for the
scans. After the operation a MRI scan is made within 72 hours.
The response to therapy will be measured in progression free period,
conventional radiological response and clinical response and be compared to the
results of MRS and FLT-PET.
After the normal treatment the FLT-PET and MRS scans will continued together
with normal follow up MRI scan depending on the results of the first 40 weeks.
Normally every 3 months.
The endpoint for the study is defined as the last patients last visit.
Secondary outcome
In the MR diagnostics protocol also diffusion- and perfusion weighted images
are included. Changes in these images during the treatment will be correlated
to the response of the tumour and compared to the results of the MRI, MRS and
PET.
Before the start of the additive chemotherapy the patients will be asked to
answer questions about the burden and convenience of the study.
Background summary
Gliomas are the most common primary brain tumours of which approximately 50%
are high grade. The current treatment for malignant gliomas is neurosurgery to
achieve maximal macroscopic debulking and additional treatment with
radiotherapy and chemotherapy. Despite this aggressive treatment 74% of the
patients with glioblastomas die within 24 months (Strupp, 2005).
Different new therapies are being developed. However, gliomas consist of
different subgroups which respond different to radiotherapy and chemotherapy
(Reardon, 2006). One major challenge is to image reliable and early the
response of the tumours to treatment in a non-invasive way. With conventional
Magnetic Resonance Imaging (MRI) this is not possible. Magnetic Resonance
Spectroscopy (MRS) and Fluorothymidine Positron Emission Tomography (FLT-PET)
are likely to be more convenient for this purpose. These techniques are not
compared before.
With this study we want to compare different diagnostic techniques for
measuring the response of glioblastoma to radiotherapy and chemotherapy.
This study is connected to the study of the biologic behaviour, molecular
background and MR diagnostics of brain tumours in the UMC St Radboud.
Study objective
The main objective of the study is to compare the diagnostic power of Magnetic
Resonance Spectroscopy, Fluorothymidine Positron Emission Tomography and
conventional MRI in measuring the response of glioblastoma to radiotherapy and
chemotherapy.
The secondary objective is combining MRS, FLT-PET, diffusion-weighted,
perfusion-weighted and conventional MRI diagnostics for measuring the response
of glioblastoma to radiotherapy and chemotherapy.
Study design
The study is an observational, longitudinal prospective pilot study.
Study burden and risks
There are no risks associated with participation in the study. Patients will
visit the hospital maximal six times after the operation.
Every visit a MRI and MRS scan is performed which takes together approximately
45 minutes, a FLT-PET scan is performed which takes approximately 15 minutes
after 1 hour waiting and a clinical examination of approximately 20 minutes is
performed. The pre-operative and MRI-MRS scan made before start of the
additional chemotherapy can replace the neuronavigation MRI and routinely
follow-up MRI respectively. The PET-CT made before start of the radiotherapy
can be used for planning of the radiotherapy.
There are no risks for the FLT-PET scan. With the exclusion criteria there is
no risk for the MRI and MRS scan. There are no direct benefits for the
patients. Patients will receive only a refund of travelling expenses.
Postbus 9101
6500 HB Nijmegen
Nederland
Postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Suspected intracranial glioblastoma on MRI eligible for operation
Contrast enhancement after gadolineum on T1-weighted MRI
Eligible for additional treatment with radiotherapy and chemotherapy after the operation
Informed consent
Adult, patients
Exclusion criteria
Karnovsky score < 70
Exclusioncriteria for MRI (eg known gadolinium allergy, pacemaker, neurostimulator, insulinepomp, defibrillator)
Patients with a post-operative proven non glioblastoma
Patients with a pre-operative non-enhancing FLT-PET scan
Pregnancy
Age > 70 years
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17354.091.07 |