None listed
Conditions
Brief summary
The aim of this study is to evaluate the the PET imaging agent, O-(2-[18F]-fluoroethyl)L-tyrosine (FET) to definitively establish the role of FET-PET in the management of brain cancer (Glioblastoma). Glioblastoma (GBM) is the most common primary brain cancer in adults representing approx. 50% of brain tumours. Standard treatment entails surgery followed by chemoradiation and then adjuvant chemotherapy. Imaging plays a key role in diagnosis, radiotherapy planning, and monitoring of treatment response in GBM. The current standard of care with respect to imaging is MRI. A alternate form of imaging has been developed using Positron Emission Tomography (PET), where tumours can be imaged by utilising a newer radiotracer (FET) which detects whether tumour cells are active. You may be eligible for this study if you are 18 years or older with a newly diagnosed brain cancer, specifically a histologically confirmed GBM IDH1 wild type or IDH1 mutant via IHC (2016 WHO grade IV glioma) following surgery. All participants in this study will continue with their usual care, and undergo additional FET-PET scans following chemo-radiation treatment, and at the time of subsequent suspected progression of disease. Group 1 patients will undergo an additional FET-PET prior to their radiation therapy at the time of their routine MRI scan for planning, Biomarkers obtained from participants tumour and blood will also be analysed. Participants will be asked to complete QOL questionnaires in their clinical assessment follow ups at 4 weeks, 3 months, 6 months and 12 months after the completion of chemo-radiation and at the time that the FET-PET3 scan is done. It is hoped that this new imaging approach with FET-PET scans will lead to more accurate assessment, and improve both treatment decisions and outcomes for patients with Glioblastoma. Currently FET-PET scans are not part of routine care for patients diagnosed with Gliobastoma. The use of FET-PET is experimental.
Interventions
Participants in this study are newly diagnosed Glioblastoma patients who will undergo post-operative chemo-radiation as per standard of care.
In addition to the current standard of care imaging with MRI, a new form of imaging has been developed where the tumours can be imaged by utilising a radio tracer FET which detects whether tumour cells are active
This study addresses an imaging based intervention assessing the additional use of FET-PET imaging throughout the patients treatment trajectory
Participants in this study are newly diagnosed Glioblastoma patients who will undergo post-operative chemo-radiation as per standard of care. In addition to the current standard of care imaging with MRI, a new form of imaging has been developed where the tumours can be imaged by utilising a radio tracer FET which detects whether tumour cells are active This study addresses an imaging based intervention assessing the additional use of FET-PET imaging throughout the patients treatment trajectory assessing FET-PET utility in 3 aspects: 1) The impact on post operative radiotherapy planning 2) Differentiation between treatment-related changes(pseudo-progression) from true tumour progression. 3) FET-PET imaging as a prognostic marker 200MBq +/- 10% of FET will be administered via a slow IV injection over 20-30seconds followed by a minimum 20mL saline flush. A head first CT followed by list mode acquisition for 40 minutes commencing at the start of the slow injection over 20-30 seconds of FET. Image acquisition commences immediately once the FET is administered. Group 1 will receive a total of 3 FET-PET scans. FET-PET1 is done at the time of post-operative radiotherapy planning. Both Group 1 and 2 will receive FET-PET2 four weeks post radiation therapy completion and FET-PET3 will be received post chemotherapy once changes are seen on routine MRIs. With the intervention of FET-PET the assessment of more accurate tumour progression in Glioblastoma patients to improve treatment decisions, outcomes and patient care is the hope.
Sponsors
Trans Tasman Radiation Oncology Group
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age greater than or equal to 18 years • Histologically confirmed newly diagnosed histologically confirmed GBM IDH1 wild type or IDH1 mutant via IHC (2016 WHO grade IV glioma) following surgery, with methylated or unmethylated MGMT promoter gene NOTE - Patients who had previous grade I-III glioma and have progressed to GBM are eligible assuming that they have not received prior cranial radiotherapy or Temozolomide for the treatment of glioma • ECOG 0-2 • Life expectancy of greater then 12 weeks • Adequate bone marrow reserve or organ function to allow Temozolomide (TMZ) -based chemotherapy, • Available tissue for MGMT and biomarker analysis • Participants capable of childbearing are using adequate contraception • Willing and able to comply with all study requirements, including treatment, timing and/or nature of required imaging and study assessments • Signed, written and informed consent Group 1 participants • Considered suitable for radiotherapy (with one of the two dose fractionation schedules outlined as below) plus concurrent TMZ followed by adjuvant TMZ Group 2 participants (entering study at Imaging time-point 2) • Are currently undergoing or have recently completed concurrent radiotherapy with TMZ and one of the two dose fractionation schedules ie. 60Gy/30 fractions or 40Gy/15 fractions, and logistically able to be recruited • Have commenced adjuvant chemo-radiation 7 weeks from surgery • Considered suitable for adjuvant TMZ-based therapy
Exclusion criteria
All participants; • Participants with implanted medical or electronic devices deemed by the MRI radiologist to be a contra-indication to performing a brain MRI scan (e.g. implanted defibrillator, cardiac pacemaker, a cochlear implant, a metallic joint prosthesis, nerve stimulators, metal pins, screws, plates, stents or surgical staples) • Any concurrent comorbidities, conditions or illness, including severe infection or medical or psychiatric conditions that may jeopardise the ability of the patient to undergo t procedures outlined in this protocol with reasonable safety or that may compromise assessment of key outcomes • History of another malignancy within 2 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment Group 1 participants; • Prior chemotherapy or recent cranial radiation within the last 2 years Group 2 participants • Patients that have a duration of more than 7 weeks from surgery to the start of RT
Outcome results
None listed