Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410625
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-27
Brief Title:
Evaluation of Response by FLT PET in Mesothelioma
Sponsor:
Ankara University
Organization:
Ankara University
Study Overview
Official Title:
Evaluation of the Response to Chemo-Therapy by FLT PET in Mesothelioma
Status:
RECRUITING
Status Verified Date:
2024-05
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:
FLT-MM
Brief Summary:
Pleural mesothelioma MPM is an aggressive tumor that affects the pleura and originates from mesothelial cells If untreated median survival is 4-12 months following diagnosis Asbestos exposure is a risk factor associated with 80 of cases After the 1980s regulations controlling the use of asbestos ensured that cases were limited Approximately 3000 new cases are diagnosed each year in the United States In general a minority of patients are candidates for surgery at the time of presentation so the mainstay of treatment is systemic chemotherapy For patients who are surgical candidates surgery is usually part of a multimodal treatment process that also includes chemotherapy andor radiotherapy Early and accurate diagnosis has a critical impact on the management of the disease due to limited response to multimodal treatments Patients are often diagnosed at an advanced stage leading to poor overall survival Thorax and upper abdomen CT imaging are standard initial imaging modalities for clinical staging of MPM Although CT identifies the general extent of the primary tumor it may not definitively identify some areas of tumor invasion There may be difficulties especially in the evaluation of chest wall and diaphragm invasion
18F-FDG PETCT has been widely used for cancer diagnosis staging treatment response and prognostic information for many years with high accuracy rates 18F-FDG PETCT provides valuable information on differentiating benign and malignant pleural abnormalities evaluating the possibility of malignant involvement of mediastinal and hilar lymph nodes and detecting distant metastases 18F-FDG PETCT identifies metastatic disease undetected on CT in approximately 10 of patients At the same time the degree of involvement SUV in FDG PET plays a role in predicting disease prognosis 18F-FDG PETCT can also be used to evaluate the treatment response in patients receiving chemotherapy but due to chemotherapy-related inflammatory changes it is necessary to wait at least 2 weeks to evaluate the treatment response
18F-Fluorothymidine FLT is a thymidine kinase 1-specific substrate that is increased in proliferating cells and is associated with the Ki-67 index a proliferation marker It allows noninvasive evaluation of cell proliferation especially the early evaluation of the response to cytotoxic chemotherapy 18F-FLT PETCT imaging has shown success in early evaluation of response to systemic endocrine chemotherapy radiotherapy and combined chemotherapy in multiple tumor types The prognostic value of a decrease in 18F-FLT uptake after initiation of treatment has also been reported
In this study it is aimed to evaluate the success of 18F-FLT PETCT in the early evaluation of the response after the first cycle of chemotherapy in patients diagnosed with mesothelioma and receiving systemic chemotherapy It is also aimed to evaluate the prognostic value of response evaluation made with this method
It is planned to prospectively include 25 patients with MPM who scheduled for chemotherapy in the study Included patients will undergo 18F-FDG PETCT before chemotherapy followed by 18F-FLT PETCT imaging within two weeks 18F-FLT PETCT will be performed on the 4th day after the 1st cycle of chemotherapy After chemotherapy is completed treatment response will be evaluated with 18F-FDG PETCT Patients will then be followed by their clinicians for relapse and progressive disease Thus the success of early 18F-FLT PETCT in predicting end of treatment response will be evaluated
18F-FDG PETCT has been widely used for cancer diagnosis staging treatment response and prognostic information for many years with high accuracy rates 18F-FDG PETCT provides valuable information on differentiating benign and malignant pleural abnormalities evaluating the possibility of malignant involvement of mediastinal and hilar lymph nodes and detecting distant metastases 18F-FDG PETCT identifies metastatic disease undetected on CT in approximately 10 of patients At the same time the degree of involvement SUV in FDG PET plays a role in predicting disease prognosis 18F-FDG PETCT can also be used to evaluate the treatment response in patients receiving chemotherapy but due to chemotherapy-related inflammatory changes it is necessary to wait at least 2 weeks to evaluate the treatment response
18F-Fluorothymidine FLT is a thymidine kinase 1-specific substrate that is increased in proliferating cells and is associated with the Ki-67 index a proliferation marker It allows noninvasive evaluation of cell proliferation especially the early evaluation of the response to cytotoxic chemotherapy 18F-FLT PETCT imaging has shown success in early evaluation of response to systemic endocrine chemotherapy radiotherapy and combined chemotherapy in multiple tumor types The prognostic value of a decrease in 18F-FLT uptake after initiation of treatment has also been reported
In this study it is aimed to evaluate the success of 18F-FLT PETCT in the early evaluation of the response after the first cycle of chemotherapy in patients diagnosed with mesothelioma and receiving systemic chemotherapy It is also aimed to evaluate the prognostic value of response evaluation made with this method
It is planned to prospectively include 25 patients with MPM who scheduled for chemotherapy in the study Included patients will undergo 18F-FDG PETCT before chemotherapy followed by 18F-FLT PETCT imaging within two weeks 18F-FLT PETCT will be performed on the 4th day after the 1st cycle of chemotherapy After chemotherapy is completed treatment response will be evaluated with 18F-FDG PETCT Patients will then be followed by their clinicians for relapse and progressive disease Thus the success of early 18F-FLT PETCT in predicting end of treatment response will be evaluated
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