A pilot study of the feasibility of 11C-MET as postoperative baseline scan in the follow-up of high-grade gliomas for the detection of tumor recurrence.
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 11C-MET-PET within 48 hours postoperatively will be assessed visually and
quantitatively and compared with the preoperative 11C-MET-PET scan. The
11C-MET-PET data will also be checked by comparison with the results of the
advanced MRI sequences.
Secondary outcome
Not applicable.
Background summary
The tracer 11C-methionine (11 C-MET) is used as a specific cell proliferation
tracer which shows metabolically active tumordeposities. A healthy brain barely
takes up 11C-MET, causing the difference between the background and the tumor
to be realively high. In addition, there is relatively little 11C-MET uptake in
inflammatory processes. This makes 11C-MET a very suitable positron emission
tomography (PET) tracer in order to differentiate between tumor progression and
therapy changes. The latter is a major clinical problem for which further
investigation is necessary.
In order to be able to make this differentiation, a direct post-operative
baseline scan is required. With regard to the advanced MRI sequences, it is
known that it is necessary to produce the post-operative baseline scan within
48 hours. After that timeframe, operation induced changes start to occur, such
as granulation tissue. In that case the interpretation of the scan is no longer
possible. Immediately postoperatively (<48 hours) 11C-MET has never been used
before. Therefore, it is unknown whether 11C-MET provides a good baseline scan
directly after surgery. This pilot will investigate the feasibility of this
11C-MET baseline scan and comparison the results with the advanced MRI
sequences.
Study objective
A pilot study of the feasibility of 11C-MET as postoperative baseline scan in
the follow-up of high-grade gliomas for the detection of tumor recurrence.
Study design
Conventional MRI, advanced MRI and 11C-MET-PET will be conducted on the same
day. The advanced MRI will consist of diffusion weighted imaging (DWI),
perfusion imaging by contrast technique (DSC) and spectroscopy (MRS). The
post-operative MRI and PET scan will be produced within 48 hours after surgery
(with the aim that operative effects are not visible on the baseline scan).
This corresponds to the current practice of conventional MRI follow-up at the
end of the radiotherapy.
The comparison with the pre-operative scan is to assess the viability of the
post-operative scan. It will assessed whether the preoperative tumor uptake
will disappear in accordance to the resection, as shown by the advanced MRI
sequences. In addition, it will be assessed whether there are no interfering
postoperative effects. The 11C-MET-PET scans will be interpreted in comparison
with the quantitative results obtained with advanced MRI sequences (perfusion /
diffusion / oxygenation / spectroscopy). If an immediate postoperative
11C-MET-PET proves to be feasible, than this will provide a basis for further
research. This future research consist out of the differentiation between tumor
progression and therapy change, one of the most urgent clinical dilemmas in
neuro-oncology.
Study burden and risks
Use of MRI and PET are very safe. The duration of the routine MRI scan will be
5 minutes longer, so 40 minutes instead of 35 minutes. A PET scan will also be
manufactured on the same day extra after intravenous injection of 11C-MET. In
total, this takes 40 minutes (20 minutes contact time and 20 minutes scan
time).
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Patients with suspicion of newly diagnosed high-grade glioma who qualify for the standard treatment. Written informed consent
Exclusion criteria
Patients with recurrent high-grade glioma or other brain tumor as a secondary diagnosis are excluded. In addition, all patients who have had previous brain surgery or radiotherapy to the brain are also excluded. Patients with only a biopsy will be excluded. Patients under the age of 18 years will not be included. General exclusion criteria for MRI are exclusion criteria for participation in this study. The general MRI exclusion criteria are: not MRI compatible ferromagnetic material, pregnancy (or presumption thereof) and claustrophobia.
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 |
|---|---|
| ClinicalTrials.gov | NCT02585219 |
| CCMO | NL50485.042.14 |