Non-invasive Evaluation of Lymphoma Patients Based on Artificial Intelligence and PET/MRI
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|ClinicalTrials.gov Identifier: NCT04154228|
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
18F-FDG PET/MR imaging protocol integrating advanced MR vascular imaging sequences, along with computerized quantitative methods for data analysis, is expected to serve as an objective tool for assessment of lymphoma patients. The aim of this prospective study is to develop an automatic artificial intelligence-based tool for the assessment of early response to treatment and evaluation of residual masses in patients with lymphoma. Specific objectives are:
- To evaluate the added value of 18F-FDG PET/MRI compared with PET/CT in imaging lymphoma.
- To optimize PET/MR imaging protocol for lymphoma assessment.
- To develop an automated tool for staging patients with lymphoma.
- To develop an automated method for early prediction of response to therapy and prognosis in patients with lymphoma.
- To develop an automated non-invasive tool for discriminating benign from active residual masses at end of treatment in patients with lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Non Hodgkin Lymphoma Follicular Lymphoma||Diagnostic Test: PET/MR scan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-invasive Evaluation of Lymphoma Patients Based on Artificial Intelligence and PET/MRI|
|Estimated Study Start Date :||December 10, 2019|
|Estimated Primary Completion Date :||January 10, 2020|
|Estimated Study Completion Date :||December 10, 2021|
|Experimental: Lymphoma Patients||
Diagnostic Test: PET/MR scan
Patients will undergo 18F-FDG PET/CT scans before therapy initiation, interim after 2/3 treatment cycles and end of treatment after therapy completion, as part of their routine evaluation, as well as additional follow-up scans, as clinically indicated and requested by referring physicians. Given signed written informed-consent forms, patients will undergo at each time point, immediately after completion of PET/CT, a PET/MR scan, following the same single injection of 18F-FDG. Standard preparation and acquisition protocols for FDG PET imaging will be employed.
PET/MR imaging will include conventional sequences as T1, T2, diffusion weighted imaging, and advanced vascular imaging (DCE-MRI).
- Patients that preform 18F-FDG PET/MRI and the routinely PET/CT [ Time Frame: 1 year ]Patients that preform 18F-FDG PET/MRI and the routinely PET/CT, and the investigators optimize PET/MRI imaging protocol, and to develop an automated artificial intelligence-based tool for assessment of early response to treatment in patients with lymphoma.