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

NCT02585219 | Unknown

• 1 other identifier: NL50485.042.14
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

High-grade Glioma Patients

Patients with suspicion of newly diagnosed high-grade glioma eligible for standard therapy (surgical resection followed by chemoradiotherapy). Patients with a second brain tumor, brain surgery earlier or prior radiotherapy to the brain are excluded. Patients with only a biopsy be excluded. The group will consist of 10 patients. This number may be adjusted for patients who are found to have a different diagnosis after histological examination or fall out. For a pilot feasibility study our experience that a number of 10 patients is sufficient for PET examination.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspicion of newly diagnosed high-grade glioma eligible for standard therapy (surgical resection followed by chemoradiotherapy). Patients with a second brain tumor, brain surgery earlier or prior radiotherapy to the brain are excluded. Patients with only a biopsy be excluded. The group will consist of 10 patients. This number may be adjusted for patients who are found to have a different diagnosis after histological examination or fall out. For a pilot feasibility study our experience that a number of 10 patients is sufficient for PET examination.

You may qualify if:

• Patients with suspicion of newly diagnosed high-grade glioma who qualify for the standard treatment. Written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nuclear Medicine Physician

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: October 23, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 23, 2015

Record last verified: 2015-10