Developing a Method Using PET-MR to Improve Staging and Monitoring of Neuroendocrine Tumor
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|ClinicalTrials.gov Identifier: NCT04154241|
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Diagnostic Test: PET/MR scan||Not Applicable|
18F-DOPA and 11C-5-HTP are used to evaluate neuroendocrine metabolism . 18-fluoro-deoxy-glucose (FDG) PET is usually a poor indication for NETs since these neoplasms tend to be metabolic inactive, and thus FDG-PET is only used for high grade more aggressive NETs . Only a combination of several biomarkers together can lead to NET description that allows treatment selection and to some extent prediction of treatment success.
In this study the investigators wish to take advantage of the new hybrid PET-MR and use it to find new methods to characterize NETs. Only very few PET-MR studies have been performed with correlation to NETs and they showed the potential of this tool for tumor characterization .
The investigators plan to integrate PET-MR with big data analysis methods to obtain an improved tool for staging, characterization and monitoring NETs.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Developing a Method Using PET-MR to Improve Staging and Monitoring of Neuroendocrine Tumor|
|Estimated Study Start Date :||March 10, 2020|
|Estimated Primary Completion Date :||May 10, 2021|
|Estimated Study Completion Date :||March 10, 2022|
Experimental: neuroendocrine tumor Patients
A cohort of patients that were diagnosed with NET using biopsy.
Diagnostic Test: PET/MR scan
The PET will be performed with (68Ga)-labeled somatostatin analogue since it was proven to be superior to other NET PET tracers in terms of lesion detection and sensitivity  . The 3 tesla magnet of the MRI should allow acquisition of several contrasts within a reasonable time frame. The protocol will include T1 and T2-weighted images, diffusion-weighted images with multiple b values and apparent diffusion coefficient (ADC) maps.
All images will be analyzed with big data tools such as radiomics and texture analysis in order to integrate all image parameters and different contrasts into individual tumor status. Then, accuracy, sensitivity and specificity will be evaluated by correlation of this data collection and analysis method with histological biomarkers (for example, Ki67 level) and treatment results.
- Patients who preformed PET/MR. [ Time Frame: 1 year ]The investigators develop new methods for the characterization and monitoring of NETs using the latest state of the art PET-MR technology combined with big data analysis methods in order to obtain a more accurate, specific and sensitive biomarker.