Advanced Imaging and Biopsy Techniques for Brain Tumor (ReGIT Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByJason Parker, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Indiana University
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial uses advanced imaging techniques to take detailed pictures of brain tumors in patients with gliomas. Researchers aim to see if these images can predict genetic changes in the tumors.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the study requires participants to be treatment-naïve for the brain tumor condition, it might imply that you should not be on any treatment for the tumor itself.
What data supports the effectiveness of this treatment for brain tumors?
Research shows that the use of O-(2-[18F]fluoroethyl)-L-tyrosine ([18F]FET) in PET scans is effective in diagnosing and managing brain tumors by providing important information for tumor delineation and treatment planning. Additionally, combining [18F]FET PET with MRI improves the accuracy of identifying tumor boundaries, which is crucial for effective treatment.
12345Are advanced imaging and biopsy techniques for brain tumors safe for humans?
Gadolinium-based contrast agents used in MRI for brain imaging are generally very safe, with mild side effects. However, there are concerns about rare risks like nephrogenic systemic fibrosis and gadolinium retention, especially in patients with kidney issues.
46789How does the advanced imaging and biopsy technique treatment for brain tumors differ from other treatments?
This treatment is unique because it uses advanced imaging techniques like dynamic contrast-enhanced MRI to guide biopsies, which helps in selecting more accurate tissue samples for diagnosis compared to standard imaging methods. This approach improves the precision of biopsy targeting, especially in non-contrast-enhancing gliomas, leading to better diagnostic outcomes.
1011121314Eligibility Criteria
This trial is for adults aged 18-89 with a newly diagnosed Grade II-IV glioma brain tumor, who can lay still for imaging tests and are planning surgery to remove the tumor. They must be able to read/write in English and not have any conditions that prevent MRI scans.Inclusion Criteria
I am between 18 and 89 years old.
My brain tumor is suspected or confirmed to be Grade II-IV glioma.
I have not received any treatment for my condition yet.
There is enough of my tumor to take at least 2 biopsy samples during surgery.
I can stay still during MRI scans.
I am scheduled for surgery to remove and biopsy my brain tumor.
Exclusion Criteria
I do not have any serious or unstable illnesses.
There isn't enough tissue for two biopsy samples during my surgery.
I have kidney issues and can't follow certain medication dosing due to my weight.
Participant Groups
The study examines how brain tumors change over time using advanced imaging techniques like MRI/PET scans combined with biopsies. It aims to see if these tools can predict genetic mutations in the tumors.
1Treatment groups
Experimental Treatment
Group I: Baseline Imaging and BiopsyExperimental Treatment5 Interventions
Subjects will receive a PET-CT with the radiopharmaceuticals FET and O-15 Water (under RDRC approval for basic research) prior to their standard of care neurosurgery via stereotactic core biopsy. Research samples will be collected for analysis intraoperatively.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Indiana University School of MedicineIndianapolis, IN
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
Children's Hospital of PhiladelphiaCollaborator
References
Current trends in the use of O-(2-[18F]fluoroethyl)-L-tyrosine ([18F]FET) in neurooncology. [2021]The diagnostic potential of PET using the amino acid analogue O-(2-[18F]fluoroethyl)-L-tyrosine ([18F]FET) in brain tumor diagnostics has been proven in many studies during the last two decades and is still the subject of multiple studies every year. In addition to standard magnetic resonance imaging (MRI), positron emission tomography (PET) using [18F]FET provides important diagnostic data concerning brain tumor delineation, therapy planning, treatment monitoring, and improved differentiation between treatment-related changes and tumor recurrence. The pharmacokinetics, uptake mechanisms and metabolism have been well described in various preclinical studies. The accumulation of [18F]FET in most benign lesions and healthy brain tissue has been shown to be low, thus providing a high contrast between tumor tissue and benign tissue alterations. Based on logistic advantages of F-18 labelling and convincing clinical results, [18F]FET has widely replaced short lived amino acid tracers such as L-[11C]methyl-methionine ([11C]MET) in many centers across Western Europe. This review summarizes the basic knowledge on [18F]FET and its contribution to the care of patients with brain tumors. In particular, recent studies about specificity, possible pitfalls, and the utility of [18F]FET PET in tumor grading and prognostication regarding the revised WHO classification of brain tumors are addressed.
Prognostic Value of O-(2-[18F]Fluoroethyl)-L-Tyrosine PET/CT in Newly Diagnosed WHO 2016 Grade II and III Glioma. [2020]Label="PURPOSE">The use of [18F]fluoroethyl)-L-tyrosine ([18F]FET) positron emission tomography/computed tomography (PET/CT) has proven valuable in brain tumor management. This study aimed to investigate the prognostic value of radiotracer uptake in newly diagnosed grade II or III gliomas according to the current 2016 World Health Organization (WHO) classification.
Simultaneous FET-PET and contrast-enhanced MRI based on hybrid PET/MR improves delineation of tumor spatial biodistribution in gliomas: a biopsy validation study. [2021]Label="PURPOSE">Glioma treatment planning requires precise tumor delineation, which is typically performed with contrast-enhanced (CE) MRI. However, CE MRI fails to reflect the entire extent of glioma. O-(2-18F-fluoroethyl)-L-tyrosine (18F-FET) PET may detect tumor volumes missed by CE MRI. We investigated the clinical value of simultaneous FET-PET and CE MRI in delineating tumor extent before treatment planning. Guided stereotactic biopsy was used to validate the findings.
Diagnostic efficacy and safety of gadoteridol compared to gadobutrol and gadoteric acid in a large sample of CNS MRI studies at 1.5T. [2022]To evaluate safety and diagnostic accuracy of gadoteridol vs. other macrocyclic gadolinium-based contrast agents (GBCAs) in a large cohort of consecutive and non-selected patients referred for CE-MRI of the CNS.
Comparison of O-(2-18F-fluoroethyl)-L-tyrosine PET and 3-123I-iodo-alpha-methyl-L-tyrosine SPECT in brain tumors. [2016]The aim of this study was to compare PET with O-(2-(18)F-fluoroethyl)-L-tyrosine ((18)F-FET) and SPECT with 3-(123)I-iodo-alpha-methyl- L-tyrosine ((123)I-IMT) in patients with brain tumors.
MR imaging advances in practice. [2019]Efficacy and safety of gadolinium contrast agents in MR imaging of the brain and spine are examined first in the context of clinical experience at the Barrow Neurological Institute. The role played by the absence and the presence of contrast enhancement in confirming or ruling out diagnostic suspicions is emphasized. Findings from multicenter phase I-III efficacy and safety studies of gadopentetate dimeglumine, gadodiamide, and gadoteridol in head and back imaging are reviewed. All three agents add diagnostic information, increase diagnostic confidence, and are extremely safe, readily tolerated compounds exhibiting generally mild side-effect profiles. Gadolinium-enhanced MR scanning is placed in the longer perspective of diagnostic imaging strategies, to consider the assignment of priorities to various modalities according to the suspected disease at hand.
Consensus Guidelines of the French Society of Neuroradiology (SFNR) on the use of Gadolinium-Based Contrast agents (GBCAs) and related MRI protocols in Neuroradiology. [2021]Gadolinium-based contrast agents (GBCAs) are used in up to 35% of magnetic resonance imaging (MRI) examinations and are associated with an excellent safety profile. Nevertheless, two main issues have arisen in the last two decades: the risk of nephrogenic systemic fibrosis and the risk of gadolinium deposition and retention. As a first step, this article reviews the different categories of GBCAs available in neuroradiology, their issues, and provides updates regarding the use of these agents in routine daily practice. Recent advances in MRI technology, as well as the development of new MRI sequences, have made GBCA injection avoidable in many indications, especially in patients with chronic diseases when iterative MRIs are required and when essential diagnostic information can be obtained without contrast enhancement. These recent advances also lead to changes in recommended MRI protocols. Thus, in a second step, this review focuses on consensus concerning brain MRI protocols in 10 common situations (acute ischemic stroke, intracerebral hemorrhage, cerebral venous thrombosis, multiple sclerosis, chronic headache, intracranial infection, intra- and extra-axial brain tumors, vestibular schwannoma and pituitary adenoma). The latter allowing the standardization of practices in neuroradiology. Recommendations were also made concerning the use of GBCAs in neuroradiology, based on evidence in the literature and/or by consensus between the different coauthors.
Efficacy of gadoteridol for contrast-enhanced magnetic resonance imaging in children. [2015]This study assesses the efficacy of gadoteridol for contrast-enhanced magnetic resonance imaging (MRI) in children.
Gadolinium-based contrast agents for imaging of the central nervous system: A multicenter European prospective study. [2022]Contrast-enhanced MR (CE-MR) imaging is required to improve lesion detection and characterization and to increase diagnostic confidence. This study aims to evaluate the safety, effectiveness, and usage patterns of recently introduced ClariscanTM (gadoterate meglumine) and other macrocyclic gadolinium-based contrast agents (GBCAs) used for magnetic resonance imaging (MRI) of the central nervous system (CNS). Data was obtained from a European multicenter, prospective, observational postmarketing study that included pediatric and adult patients undergoing contrast-enhanced MRI with a GBCA used in routine clinical practice. Safety data was collected by spontaneous patient adverse event (AE) reporting. Effectiveness was assessed via changes in radiological diagnosis, diagnostic confidence, and image quality. 766 patients with CNS-related indications were included from 8 centers across 5 European countries between December 2018 and November 2019. Clariscan (gadoterate meglumine) was used in 66% (503) of exams, Dotarem® (gadoterate meglumine) in 20% (160), Gadovist® (gadobutrol) in 13% (97), and ProHance® (gadoteridol) in 1%. GBCA use increased the diagnostic confidence in 95% (724/766) of patients and a change in radiological diagnosis in 65% (501/766) of patients. The Clariscan-specific data revealed an increase in diagnostic confidence in 94% (472/503) of patients and resulted in a change in radiological diagnosis in 58% (293/503) of patients. Image quality was considered excellent or good in 95% of patients across all GBCAs and in 94% of patients who received Clariscan. No AEs were reported in this cohort including Clariscan. This data demonstrates the excellent safety and efficacy profile of Clariscan and other GBCAs used in MRI examination of the CNS.
Stereotactic indications for neuroradiological differential diagnosis. [2019]The modern neurodiagnostic techniques of MR imaging, CT scanning and angiography provide valuable morphological information that, although highly sensitive to tumour localisation, still lacks comparable specificity as to the exact histological nature of those lesions demonstrated. Biopsy remains necessary. To patients with potentially inoperable lesions or lesions best treated by chemotherapy or irradiation, modern techniques of neurosurgery now offer the option of precise stereotactic biopsy through small twist-drill burr holes as opposed to open biopsy. The interrelationships between MR, CT, angiography and stereotactic biopsy and their respective roles in the establishment of a definitive diagnosis are discussed.
Advanced Imaging for Biopsy Guidance in Primary Brain Tumors. [2020]Accurate glioma sampling is required for diagnosis and establishing eligibility for relevant clinical trials. MR-based perfusion and spectroscopy sequences supplement conventional MR in noninvasively predicting the areas of highest tumor grade for biopsy. We report the case of a patient with gliomatosis cerebri and multifocal patchy enhancement in whom the combination of advanced and conventional imaging attributes successfully guided a diagnostic biopsy.
Intra-individual comparison of ¹⁸F-FET and ¹⁸F-DOPA in PET imaging of recurrent brain tumors. [2022]Both (18)F-fluorodihydroxyphenylalanine ((18)F-DOPA) and (18)F-fluoroethyltyrosine ((18)F-FET) have already been used successfully for imaging of brain tumors. The aim of this study was to evaluate differences between these 2 promising tracers to determine the consequences for imaging protocols and the interpretation of findings.
Biopsy targeting with dynamic contrast-enhanced versus standard neuronavigation MRI in glioma: a prospective double-blinded evaluation of selection benefits. [2019]Current biopsy planning based on contrast-enhanced T1W (CET1W) or FLAIR sequences frequently delivers biopsy samples that are not in concordance with the gross tumor diagnosis. This study investigates whether the quantitative information of transfer constant Ktrans maps derived from T1W dynamic contrast-enhanced MRI (DCE-MRI) can help enhance the quality of biopsy target selection in glioma. 28 patients with suspected glioma received MRI including DCE-MRI and a standard neuronavigation protocol of 3D FLAIR- and CET1W data sets (0.1 mmol/kg gadobutrol) at 3.0 T. After exclusion of five cases with no Ktrans-elevation, 2-6 biopsy targets were independently selected by a neurosurgeon (samples based on standard imaging) and a neuroradiologist (samples based on kinetic parameter Ktrans) per case and tissue samples corresponding to these targets were collected by a separate independent neurosurgeon. Standard technique and Ktrans-based samples were rated for diagnostic concordance with the gross tumor resection reference diagnosis (67 WHO IV; 24 WHO III and II) by a neuropathologist blinded for selection mode. Ktrans-based sample targets differed from standard technique sample targets in 90/91 cases. More Ktrans-based than standard imaging-based samples could be extracted. Diagnoses from Ktrans-based samples were more frequently concordant with the reference gross tumor diagnoses than those from standard imaging-based samples (WHO IV: 30/39 vs. 11/20; p = 0.08; WHO III/II: 12/13 vs. 6/11; p = 0.06). In 4/5 non-contrast-enhancing gliomas, Ktrans-based selection revealed significantly more accurate samples than standard technique sample-selection (10/12 vs. 2/8 samples; p = 0.02). If Ktrans elevation is present, Ktrans-based biopsy targeting provides significantly more diagnostic tissue samples in non-contrast-enhancing glioma than selection based on CET1W and FLAIR-weighted images alone.
Comparison of 18F-FET PET and perfusion-weighted MR imaging: a PET/MR imaging hybrid study in patients with brain tumors. [2016]PET using O-(2-(18)F-fluoroethyl)-L-tyrosine ((18)F-FET) provides important diagnostic information in addition to that from conventional MR imaging on tumor extent and activity of cerebral gliomas. Recent studies suggest that perfusion-weighted MR imaging (PWI), especially maps of regional cerebral blood volume (rCBV), may provide similar diagnostic information. In this study, we directly compared (18)F-FET PET and PWI in patients with brain tumors.