[18F] FDOPA PET Imaging in Glioma: Feasibility Study for PET Guided Brain Biopsy (FIG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04870580|
Recruitment Status : Not yet recruiting
First Posted : May 3, 2021
Last Update Posted : July 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Glioma||Diagnostic Test: Fluorodopa PET tracer||Not Applicable|
Glioma is a cancer of unmet need, where survival trends have not significantly changed for decades. The distinction between high-grade (HGG) and low-grade glioma (LGG) is important as both entities confer different prognoses and management strategies. This distinction is normally made on biopsy sampling and conventional imaging. However, sampling errors are not uncommon due to the heterogeneous nature of glioma. Case series have described under-grading of gliomas on biopsy in 28% to 63% of cases. Furthermore, up to one third of high-grade gliomas may not display the typical imaging characteristics (enhancement) of a high-grade glioma. Therefore, more accurate imaging may help to make this distinction and guide biopsy and clinical management decisions at the outset.
There has been growing interest in the use of amino acid PET in glioma imaging. Transport of amino acids across the blood brain barrier and low physiological levels of tracer uptake within the brain allow for good tumour visualisation. The most frequently used amino acid PET tracers described in clinical literature are [11C]methionine, [18F]fluoroethyltyrosine and [18F]fluorodopa, which predominantly reflect leucine transport, being mainly transported by LAT1, a high affinity leucine transporter. Alongside depiction of tumour volume, described roles of amino acid PET include differentiation of true disease progression from pseudo progression, detection of residual disease in the post-surgical patient, biopsy guidance and prognostication.
Rationale The primary objective of the study will be to establish the feasibility of performing [18F]fluorodopa PET guided histopathology in a single and multi-site setting. Basic tumour characterisation (for example Ki67 expression and detection of IDH mutations) will be undertaken.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||[18F] FDOPA PET Imaging in Glioma: Feasibility Study for PET Guided Brain Biopsy|
|Estimated Study Start Date :||September 1, 2021|
|Estimated Primary Completion Date :||May 1, 2023|
|Estimated Study Completion Date :||May 1, 2023|
PET/CT with fluorodopa tracer
Diagnostic Test: Fluorodopa PET tracer
PET/CT scan using fluorodopa tracer
- To assess the feasibility of PET guided histopathology in a single and multi-site setting. [ Time Frame: 2 years ]Assessment of tumour standardised uptake values (SUV) from [18F]fluorodopa PET with matched histopathology data from biopsies for evaluable patients from a single site and multiple sites. The percentage of cases where it is possible to collect this data will inform the feasibility of performing the assessments in a single-site and multi-site setting with a 70% threshold used to determine feasibility.
- To investigate the inter-observer variation (IOV) in tumour to background uptake measurements to assess reliability. [ Time Frame: 2 years ]IOV in tumour to background uptake measurements
- To characterise dopamine uptake in high-grade glioma and low-grade glioma. [ Time Frame: 2 years ]SUV/TBR corresponding to the optimal cut-off value for high-grade and low-grade glioma on receiver operating characteristic curve analysis.
- To provide data on the proportion of high-grade transformation in low-grade glioma. [ Time Frame: 2 years ]Proportion of patients showing high-grade transformation following histopathology.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04870580
|Contact: JOY ROACH||01865 firstname.lastname@example.org|
|Principal Investigator:||Geoffrey Higgins||University College, London|