Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466031
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-02
Brief Title:
Application of MET-PET in Fusion With MRI in the Treatment of Glioblastoma Multiforme
Sponsor:
Copernicus Memorial Hospital
Organization:
Copernicus Memorial Hospital
Study Overview
Official Title:
Application of MET-PET in Fusion With MRI in the Surgical Treatment and Postoperative Radiotherapy of Glioblastoma Multiforme - a Randomized Blinded Prospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Glioblastoma multiforme GBM IV WHO is the most common primary neoplasm of brain in the adults Simultanously it is the most agressive one of all primary brain tumors Despite the treatment the outcome in that group of patients is poor In case of the optimal therapy the estimated median of survival ranges between 12 and 16 months The present standard of treatment embraces the gross total resection with the preserved neurological functions and the posoperative management according to the Stupps protocol fractionated radiotherapy of 60 Gy dose and the chemotherapy with Temozolamide
Annually the incidence rate of GBM is 5100000 of population According to the National Tumor Registry 2494 people went down to the malignant neoplasmatic disease of brain classified as C71 ICD-10 in 2020 The evaluation indicates that it is 600 new patients with the diagnosis of GBM The disease becomes the 9th cause of death among males and the 13th one among females The peak of incidence appears in the 5th decade of life and concerns the most productive population Routinely the management embraces the planning of the resection surgery based on the preoperative magnetic resonance investigation MRI with contrast The common image of the tumor allows to put the preliminary diagnosis with the high probability rate The GBM occurs as the enhanced tumor with the central necrosis and the circumferential brain edema visible in T2 and Flair sequences of MRI Commonly the border of tumor becomes the line of contrast enhancement The enhances area is the aim of surgical treatment The lack of the preoperative enhanced area in the postoperative MRI is assumed as the gross total resection GTR It has been proved that the range of the resection translates into the overall survival OS and the progression free survival PFS Despite the resection classified as GTR the relapse in the operated area often occurs It can be explained by the presence of the glioma stem cells in the surrounding neuronal tissue They are responsible for the early relapse of GBM Notably it is evident that the MRI with contrast becomes the method which does not reveal the proper range of resection with the relevant sensitivity so as to extend PFS and OS The positron emission tomography PET is one of the diagnostic methods having been clinically evaluated PET assesses the metabolic demand of the neoplasm for the biochemical substrates That methodology is commonly used in case of severity of the solid tumors The fluorodeoxyglucose 18-FDG is the most frequently used However the high metabolism of glucose within the brain particularly in the grey matter 18-FDG has the limitation in the process of planning of the tumor resection The higher specificity and sensitivity are elicited among the markers including aminoacids praticularly 11-C methionine 11C-MET Within the gliomas the higher uptake is observed than in the healthy brain The range of the contrast enhancement in the MRI covers only 58 of the higher 11C-MET metabolism Comparing these results with a tumor resection beyond the enhancement area indicates the necessity of the precise assessment of the proposed method in the routine planning of the glioma resection
Current body of literature lacks in high quality research concerning that issue The articles regarding the glioma resection beyond the GTR may be found instead The surgery is limited to the resection of brain area with the incorrect signal in the FLAIR sequence suspected of the presence of glioma stem cells The described technique allows to extend PFS by for about 2 months In that case the resection is based mainly on the FLAIR sequence which does not determine the presence of the neoplasm therein The fusion of the MRI and the MET-PET images would allow to plan the resection so as to cover the area of incorrectly increased marker uptake
Annually the incidence rate of GBM is 5100000 of population According to the National Tumor Registry 2494 people went down to the malignant neoplasmatic disease of brain classified as C71 ICD-10 in 2020 The evaluation indicates that it is 600 new patients with the diagnosis of GBM The disease becomes the 9th cause of death among males and the 13th one among females The peak of incidence appears in the 5th decade of life and concerns the most productive population Routinely the management embraces the planning of the resection surgery based on the preoperative magnetic resonance investigation MRI with contrast The common image of the tumor allows to put the preliminary diagnosis with the high probability rate The GBM occurs as the enhanced tumor with the central necrosis and the circumferential brain edema visible in T2 and Flair sequences of MRI Commonly the border of tumor becomes the line of contrast enhancement The enhances area is the aim of surgical treatment The lack of the preoperative enhanced area in the postoperative MRI is assumed as the gross total resection GTR It has been proved that the range of the resection translates into the overall survival OS and the progression free survival PFS Despite the resection classified as GTR the relapse in the operated area often occurs It can be explained by the presence of the glioma stem cells in the surrounding neuronal tissue They are responsible for the early relapse of GBM Notably it is evident that the MRI with contrast becomes the method which does not reveal the proper range of resection with the relevant sensitivity so as to extend PFS and OS The positron emission tomography PET is one of the diagnostic methods having been clinically evaluated PET assesses the metabolic demand of the neoplasm for the biochemical substrates That methodology is commonly used in case of severity of the solid tumors The fluorodeoxyglucose 18-FDG is the most frequently used However the high metabolism of glucose within the brain particularly in the grey matter 18-FDG has the limitation in the process of planning of the tumor resection The higher specificity and sensitivity are elicited among the markers including aminoacids praticularly 11-C methionine 11C-MET Within the gliomas the higher uptake is observed than in the healthy brain The range of the contrast enhancement in the MRI covers only 58 of the higher 11C-MET metabolism Comparing these results with a tumor resection beyond the enhancement area indicates the necessity of the precise assessment of the proposed method in the routine planning of the glioma resection
Current body of literature lacks in high quality research concerning that issue The articles regarding the glioma resection beyond the GTR may be found instead The surgery is limited to the resection of brain area with the incorrect signal in the FLAIR sequence suspected of the presence of glioma stem cells The described technique allows to extend PFS by for about 2 months In that case the resection is based mainly on the FLAIR sequence which does not determine the presence of the neoplasm therein The fusion of the MRI and the MET-PET images would allow to plan the resection so as to cover the area of incorrectly increased marker uptake
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None