Pilot Viability of 11C-MET-PET as a Post-surgery Baseline Scan in High-grade Gliomas

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02585219
• Other study ID #: NL50485.042.14
• Status: Not yet recruiting
• Phase: N/A
• First received: October 21, 2015
• Last updated: October 22, 2015
• Start date: January 2016
• Est. completion date: July 2017

Study information

• Verified date: October 2015
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: July 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glioblastoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual comparison of pre- and post-surgery 11C-MET-PET	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. Specifically the comparison will include evaluation of surgical success (all former positive 11C-MET uptake removed) and evaluation of possible post-surgical effects on the second 11C-MET-PET.	1 week between pre- and post-surgery 11C-MET-PET	No