[18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial
Introduction Glioblastoma is the most common aggressive primary central nervous system cancer in adults characterised by uniformly poor survival. Despite maximal safe resection and postoperative radiotherapy with concurrent and adjuvant temozolomide-based chemotherapy, tumours inevitably recur. Imag...
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BMJ Publishing Group
2023-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/8/e071327.full |
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| author | Eng-Siew Koh Mustafa Khasraw Elizabeth H Barnes Kyle M Walsh Mark Rosenthal Rodney J Hicks Farshad Foroudi Hui K Gan Anna K Nowak Dale L Bailey Paul Roach Arian Lasocki Robyn Leonard Roel Verhaak Andrew M Scott Alisha Moore Bradford A Moffat Clare Senko Roslyn J Francis Martin Ebert Sze Ting Lee Eddie Lau Greg Fitt Robert Coffey Richard De Abreu Lourenco Lucas Adda Paul A Thomas Michael Back |
| author_facet | Eng-Siew Koh Mustafa Khasraw Elizabeth H Barnes Kyle M Walsh Mark Rosenthal Rodney J Hicks Farshad Foroudi Hui K Gan Anna K Nowak Dale L Bailey Paul Roach Arian Lasocki Robyn Leonard Roel Verhaak Andrew M Scott Alisha Moore Bradford A Moffat Clare Senko Roslyn J Francis Martin Ebert Sze Ting Lee Eddie Lau Greg Fitt Robert Coffey Richard De Abreu Lourenco Lucas Adda Paul A Thomas Michael Back |
| author_sort | Eng-Siew Koh |
| collection | DOAJ |
| description | Introduction Glioblastoma is the most common aggressive primary central nervous system cancer in adults characterised by uniformly poor survival. Despite maximal safe resection and postoperative radiotherapy with concurrent and adjuvant temozolomide-based chemotherapy, tumours inevitably recur. Imaging with O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) positron emission tomography (PET) has the potential to impact adjuvant radiotherapy (RT) planning, distinguish between treatment-induced pseudoprogression versus tumour progression as well as prognostication.Methods and analysis The FET-PET in Glioblastoma (FIG) study is a prospective, multicentre, non-randomised, phase II study across 10 Australian sites and will enrol up to 210 adults aged ≥18 years with newly diagnosed glioblastoma. FET-PET will be performed at up to three time points: (1) following initial surgery and prior to commencement of chemoradiation (FET-PET1); (2) 4 weeks following concurrent chemoradiation (FET-PET2); and (3) within 14 days of suspected clinical and/or radiological progression on MRI (performed at the time of clinical suspicion of tumour recurrence) (FET-PET3). The co-primary outcomes are: (1) to investigate how FET-PET versus standard MRI impacts RT volume delineation and (2) to determine the accuracy and management impact of FET-PET in distinguishing pseudoprogression from true tumour progression. The secondary outcomes are: (1) to investigate the relationships between FET-PET parameters (including dynamic uptake, tumour to background ratio, metabolic tumour volume) and progression-free survival and overall survival; (2) to assess the change in blood and tissue biomarkers determined by serum assay when comparing FET-PET data acquired prior to chemoradiation with other prognostic markers, looking at the relationships of FET-PET versus MRI-determined site/s of progressive disease post chemotherapy treatment with MRI and FET-PET imaging; and (3) to estimate the health economic impact of incorporating FET-PET into glioblastoma management and in the assessment of post-treatment pseudoprogression or recurrence/true progression. Exploratory outcomes include the correlation of multimodal imaging, blood and tumour biomarker analyses with patterns of failure and survival.Ethics and dissemination The study protocol V.2.0 dated 20 November 2020 has been approved by a lead Human Research Ethics Committee (Austin Health, Victoria). Other clinical sites will provide oversight through local governance processes, including obtaining informed consent from suitable participants. The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. Results of the FIG study (TROG 18.06) will be disseminated via relevant scientific and consumer forums and peer-reviewed publications.Trial registration number ANZCTR ACTRN12619001735145 |
| first_indexed | 2024-03-12T17:32:01Z |
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| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T17:32:01Z |
| publishDate | 2023-08-01 |
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| series | BMJ Open |
| spelling | doaj.art-d8d21057c5584e9388379c1d9d0c188d2023-08-04T18:25:07ZengBMJ Publishing GroupBMJ Open2044-60552023-08-0113810.1136/bmjopen-2022-071327[18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trialEng-Siew Koh0Mustafa Khasraw1Elizabeth H Barnes2Kyle M Walsh3Mark Rosenthal4Rodney J Hicks5Farshad Foroudi6Hui K Gan7Anna K Nowak8Dale L Bailey9Paul Roach10Arian Lasocki11Robyn Leonard12Roel Verhaak13Andrew M Scott14Alisha Moore15Bradford A Moffat16Clare Senko17Roslyn J Francis18Martin Ebert19Sze Ting Lee20Eddie Lau21Greg Fitt22Robert Coffey23Richard De Abreu Lourenco24Lucas Adda25Paul A Thomas26Michael Back27Radiation Oncology, Liverpool Hospital, Liverpool, New South Wales, AustraliaPreston Robert Tisch Brain Tumor Center at Duke, Department of Neurosurgery, Duke University Medical Center, Durham, North Carolina, USANHMRC Clinical Trials Centre, Camperdown, New South Wales, Australia3 Department of Pathology, Duke University School of Medicine, Durham, North Carolina, USAMedical Oncology, Royal Melbourne Hospital, Melbourne, Victoria, AustraliaSt Vincent`s Hospital Department of Medicine, University of Melbourne, Melbourne, Victoria, AustraliaDepartment of Radiation Oncology, Austin Health, Heidelberg, Victoria, AustraliaSchool of Medicine, University of Melbourne, Melbourne, Victoria, AustraliaAsbestos Diseases Research Institute, Sydney, New South Wales, AustraliaDepartment of Medicine, Sydney Medical School, University of Sydney, Camperdown, AustraliaGeneral & Oncologic Surgery, Lovell FHCC Department of Surgery, North Chicago, Illinois, USASir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, AustraliaNHMRC Clinical Trials Centre, Camperdown, New South Wales, AustraliaThe Jackson Laboratory for Genomic Medicine, Farmington, Connecticut, USASchool of Cancer Medicine, La Trobe University, Melbourne, Victoria, Australia3 Trans-Tasman Radiation Oncology Group Cancer Research, Newcastle, New South Wales, AustraliaMelbourne Brain Centre Imaging Unit, Department of Radiology, University of Melbourne, Melbourne, Victoria, AustraliaSchool of Cancer Medicine, La Trobe University, Melbourne, Victoria, AustraliaDepartment of Nuclear Medicine, Sir Charles Gairdner Hospital, Nedlands, Western Australia, AustraliaDepartment of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia, AustraliaSchool of Cancer Medicine, La Trobe University, Melbourne, Victoria, AustraliaDepartment of Molecular Imaging and Therapy, Austin Health, Heidelberg, Victoria, AustraliaDepartment of Radiology, University of Melbourne, Melbourne, Victoria, AustraliaEpithelial Biology Center, Vanderbilt University Medical Center, Nashville, Tennessee, USACentre for Health Economics Research and Evaluation, University of Technology Sydney, Broadway, New South Wales, AustraliaThe Cooperative Trials Group for Neuro-Oncology (COGNO) Consumer Advisor Panel, National Health and Medical Research Council (NHMRC) Clinical Trials Centre (CTC), University of Sydney, Sydney, New South Wales, AustraliaDepartment of Nuclear Medicine, Royal Brisbane and Women’s Hospital, Brisbane, Queensland, AustraliaDepartment of Radiation Oncology, Royal North Shore Hospital, St Leonards, New South Wales, AustraliaIntroduction Glioblastoma is the most common aggressive primary central nervous system cancer in adults characterised by uniformly poor survival. Despite maximal safe resection and postoperative radiotherapy with concurrent and adjuvant temozolomide-based chemotherapy, tumours inevitably recur. Imaging with O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) positron emission tomography (PET) has the potential to impact adjuvant radiotherapy (RT) planning, distinguish between treatment-induced pseudoprogression versus tumour progression as well as prognostication.Methods and analysis The FET-PET in Glioblastoma (FIG) study is a prospective, multicentre, non-randomised, phase II study across 10 Australian sites and will enrol up to 210 adults aged ≥18 years with newly diagnosed glioblastoma. FET-PET will be performed at up to three time points: (1) following initial surgery and prior to commencement of chemoradiation (FET-PET1); (2) 4 weeks following concurrent chemoradiation (FET-PET2); and (3) within 14 days of suspected clinical and/or radiological progression on MRI (performed at the time of clinical suspicion of tumour recurrence) (FET-PET3). The co-primary outcomes are: (1) to investigate how FET-PET versus standard MRI impacts RT volume delineation and (2) to determine the accuracy and management impact of FET-PET in distinguishing pseudoprogression from true tumour progression. The secondary outcomes are: (1) to investigate the relationships between FET-PET parameters (including dynamic uptake, tumour to background ratio, metabolic tumour volume) and progression-free survival and overall survival; (2) to assess the change in blood and tissue biomarkers determined by serum assay when comparing FET-PET data acquired prior to chemoradiation with other prognostic markers, looking at the relationships of FET-PET versus MRI-determined site/s of progressive disease post chemotherapy treatment with MRI and FET-PET imaging; and (3) to estimate the health economic impact of incorporating FET-PET into glioblastoma management and in the assessment of post-treatment pseudoprogression or recurrence/true progression. Exploratory outcomes include the correlation of multimodal imaging, blood and tumour biomarker analyses with patterns of failure and survival.Ethics and dissemination The study protocol V.2.0 dated 20 November 2020 has been approved by a lead Human Research Ethics Committee (Austin Health, Victoria). Other clinical sites will provide oversight through local governance processes, including obtaining informed consent from suitable participants. The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. Results of the FIG study (TROG 18.06) will be disseminated via relevant scientific and consumer forums and peer-reviewed publications.Trial registration number ANZCTR ACTRN12619001735145https://bmjopen.bmj.com/content/13/8/e071327.full |
| spellingShingle | Eng-Siew Koh Mustafa Khasraw Elizabeth H Barnes Kyle M Walsh Mark Rosenthal Rodney J Hicks Farshad Foroudi Hui K Gan Anna K Nowak Dale L Bailey Paul Roach Arian Lasocki Robyn Leonard Roel Verhaak Andrew M Scott Alisha Moore Bradford A Moffat Clare Senko Roslyn J Francis Martin Ebert Sze Ting Lee Eddie Lau Greg Fitt Robert Coffey Richard De Abreu Lourenco Lucas Adda Paul A Thomas Michael Back [18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial BMJ Open |
| title | [18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial |
| title_full | [18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial |
| title_fullStr | [18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial |
| title_full_unstemmed | [18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial |
| title_short | [18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial |
| title_sort | 18f fluoroethyl l tyrosine fet in glioblastoma fig trog 18 06 study protocol for a prospective multicentre pet ct trial |
| url | https://bmjopen.bmj.com/content/13/8/e071327.full |
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