Glioblastoma Clinical Trial
Official title:
Pilot Feasibility of 11C-MET-PET as a Post-surgery Baseline Scan in the Follow-up of High-grade Gliomas for the Detection of Tumor Recurrence.
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.
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.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05664243 -
A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma
|
Phase 1/Phase 2 | |
| Completed |
NCT02768389 -
Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma
|
Early Phase 1 | |
| Recruiting |
NCT05635734 -
Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma
|
Phase 1/Phase 2 | |
| Completed |
NCT03679754 -
Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102
|
Phase 1 | |
| Completed |
NCT01250470 -
Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma
|
Phase 1 | |
| Terminated |
NCT03927222 -
Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma
|
Phase 2 | |
| Recruiting |
NCT03897491 -
PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma
|
Phase 2 | |
| Active, not recruiting |
NCT03587038 -
OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma
|
Phase 1 | |
| Completed |
NCT01922076 -
Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas
|
Phase 1 | |
| Recruiting |
NCT04391062 -
Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma
|
Phase 2 | |
| Active, not recruiting |
NCT03661723 -
Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma
|
Phase 2 | |
| Active, not recruiting |
NCT02655601 -
Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001
|
Phase 2 | |
| Completed |
NCT02206230 -
Trial of Hypofractionated Radiation Therapy for Glioblastoma
|
Phase 2 | |
| Completed |
NCT03493932 -
Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade
|
Phase 1 | |
| Terminated |
NCT02709889 -
Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06058988 -
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
|
Phase 2 | |
| Completed |
NCT03018288 -
Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)
|
Phase 2 | |
| Withdrawn |
NCT03980249 -
Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells
|
Early Phase 1 | |
| Not yet recruiting |
NCT04552977 -
A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma
|
Phase 2 | |
| Withdrawn |
NCT02876003 -
Efficacy and Safety of G-202 in PSMA-Positive Glioblastoma
|
Phase 2 |