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RecruitingLast updated: 12 February 2024

FIG: This study is evaluating whether a new approach to imaging (FET-PET scans) will lead to more accurate assessment and management of brain cancerA prospective, multicentre trial evaluating the use of O-(2-[18F]-fluoroethyl)-L-tyrosine Positron Emission Tomography (FET-PET) imaging in radiotherapy planning and clinical management of people with glioblastoma.

Clinical summary

Summary

Imaging plays a key role in diagnosis, radiation therapy planning and monitoring of the treatment response of glioblastoma (GBM). The current standard of care with respect to imaging is MRI scans. An 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. All participants in this study will continue their usual care, and undergo additional FET-PET scans following chemo-radiation treatment, and at the time of subsequent suspected progression of disease. Participants will be allocated into two groups. Group 1 will receive a total of 3 FET-PET scans. FET-PET scan 1 is done at the time of post-operative radiation therapy planning. Both Groups 1 and 2 will receive FET-PET scan2 four weeks after radiation therapy is complete and FET-PET scan 3 will be received post chemotherapy once changes are seen on routine MRIs.

Conditions

This trial is treating patients with glioblastoma who have had surgery

Cancer

Brain and Spinal Cancers Brain and Spinal

Age

People18+

Phase

Not applicable

Trial Acronym

FIG

More information

Trial Identifiers

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Trial sponsor

Olivia Newton-John Cancer Research Institute,ARTnet: Australasian Radiopharmaceutical Trials Network

Scientific Title

A prospective, multicentre trial evaluating the use of O-(2-[18F]-fluoroethyl)-L-tyrosine Positron Emission Tomography (FET-PET) imaging in radiotherapy planning and clinical management of people with glioblastoma.

Eligibility

Inclusion

 

• 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

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 R

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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