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[18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial.

Publication ,  Journal Article
Koh, E-S; Gan, HK; Senko, C; Francis, RJ; Ebert, M; Lee, ST; Lau, E; Khasraw, M; Nowak, AK; Bailey, DL; Moffat, BA; Fitt, G; Hicks, RJ ...
Published in: BMJ Open
August 4, 2023

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.

Duke Scholars

Published In

BMJ Open

DOI

EISSN

2044-6055

Publication Date

August 4, 2023

Volume

13

Issue

8

Start / End Page

e071327

Location

England

Related Subject Headings

  • Tyrosine
  • Prospective Studies
  • Positron-Emission Tomography
  • Positron Emission Tomography Computed Tomography
  • Neoplasm Recurrence, Local
  • Multicenter Studies as Topic
  • Magnetic Resonance Imaging
  • Humans
  • Glioblastoma
  • Ficus
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Koh, E.-S., Gan, H. K., Senko, C., Francis, R. J., Ebert, M., Lee, S. T., … Scott, A. M. (2023). [18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial. BMJ Open, 13(8), e071327. https://doi.org/10.1136/bmjopen-2022-071327
Koh, Eng-Siew, Hui K. Gan, Clare Senko, Roslyn J. Francis, Martin Ebert, Sze Ting Lee, Eddie Lau, et al. “[18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial.BMJ Open 13, no. 8 (August 4, 2023): e071327. https://doi.org/10.1136/bmjopen-2022-071327.
Koh E-S, Gan HK, Senko C, Francis RJ, Ebert M, Lee ST, et al. [18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial. BMJ Open. 2023 Aug 4;13(8):e071327.
Koh, Eng-Siew, et al. “[18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial.BMJ Open, vol. 13, no. 8, Aug. 2023, p. e071327. Pubmed, doi:10.1136/bmjopen-2022-071327.
Koh E-S, Gan HK, Senko C, Francis RJ, Ebert M, Lee ST, Lau E, Khasraw M, Nowak AK, Bailey DL, Moffat BA, Fitt G, Hicks RJ, Coffey R, Verhaak R, Walsh KM, Barnes EH, De Abreu Lourenco R, Rosenthal M, Adda L, Foroudi F, Lasocki A, Moore A, Thomas PA, Roach P, Back M, Leonard R, Scott AM. [18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial. BMJ Open. 2023 Aug 4;13(8):e071327.

Published In

BMJ Open

DOI

EISSN

2044-6055

Publication Date

August 4, 2023

Volume

13

Issue

8

Start / End Page

e071327

Location

England

Related Subject Headings

  • Tyrosine
  • Prospective Studies
  • Positron-Emission Tomography
  • Positron Emission Tomography Computed Tomography
  • Neoplasm Recurrence, Local
  • Multicenter Studies as Topic
  • Magnetic Resonance Imaging
  • Humans
  • Glioblastoma
  • Ficus