None listed
Conditions
Brief summary
This study is investigating the effectiveness of new imaging techniques in determining prognosis and treatment response in patients with glioblastoma. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been newly diagnosed with glioblastoma grade IV, for which your are planned to undergo radiotherapy or combined chemoradiotherapy. Study details All participants in this study will undergo either 2 (group B) or 3 (group A) PET scans, scheduled around their routine radiotherapy, these scans would not normally be part of their routine care. The scans are known as O-(2-[18F]-fluoroethyl)-L-tyrosine Positron Emission Tomography (FET-PET), and involve injection of a radioactive tracer to perform a PET scan. You will need to fast for a minimum of 4 hours before the scan. You will also need to provide a small blood sample when attending for your first PET scan. We will also ask for permission to access tumour tissue samples that were collected during your previous surgery. Participants will be followed up after treatment in order to determine overall survival and disease progression. This information will be used to evaluate the usefulness of the FET-PET scans in predicting prognosis and in identifying treatment-resistant tumours. There are no additional appointments to attend outside your normal treatment visits except for the PET scan visits, which should take approximately one hour. All followup data will be collected from your medical notes when you attend your routine treatment appointments.
Interventions
O-(2-[18F]-fluoroethyl)-L-tyrosine Positron Emission Tomography (FET-PET) scans will be performed on all study participants pre and post radiotherapy. Patients will be instructed to fast for a minimum of 4 hours prior to administration of 200 MBq of F18-FET through an iv cannula. Pre-treatment scans are within 4 weeks of start of radiotherapy and post-treatment scans are 7-14 days after completion of radiotherapy. The first 20 participants (Group A) will undergo an additional pre-treatment PET s
O-(2-[18F]-fluoroethyl)-L-tyrosine Positron Emission Tomography (FET-PET) scans will be performed on all study participants pre and post radiotherapy. Patients will be instructed to fast for a minimum of 4 hours prior to administration of 200 MBq of F18-FET through an iv cannula. Pre-treatment scans are within 4 weeks of start of radiotherapy and post-treatment scans are 7-14 days after completion of radiotherapy. The first 20 participants (Group A) will undergo an additional pre-treatment PET scan 7-10 days after the first pre-treatment PET scan (a total of 3 PET scans). The remainder of participants (group B) will complete 1 pre and 1 post treatment PET scan . Each participant will also provide a small blood sample prior to the first PET scan for future analysis (yet to be determined). Duration of the imaging scan is approximately 30 minutes and patients are imaged immediately after tracer injection.
Sponsors
Sir Charles Gairdner Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with newly diagnosed, histologically confirmed glioblastoma grade IV. Planned to undergo radiotherapy or combined chemoradiotherapy ECOG performance status 0-2 Able to undertake PET imaging Able to provide written informed consent
Exclusion criteria
Pregnancy Age < 18 yrs Medical contraindication to PET imaging Cognitive impairment resulting in inability to provide informed consent.
Outcome results
None listed