FIG / TROG 18.06

Prospective, multicentre trial evaluating O-(2-[18F]-fluoroethyl)-L-tyrosine Positron Emission Tomography in Glioblastoma (FET-PET in Glioblastoma)

Trial summary:

The FIG trial is investigating how the addition of FET-PET imaging to standard MRI imaging affects radiation target volume delineation and treatment planning for Glioblastoma, as well as determining the accuracy and management impact of FET-PET in distinguishing pseudoprogression from true tumour progression and / or tumour recurrence.

Receptor status / problem studied:

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

• 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

View more trial information

Open for recruitment

Trial Title

FIG / TROG 18.06


Brain cancer

Type of trial


Type of treatement

Radiation Oncology





Principal Investigator
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