Non-invasive Evaluation of Lymphoma Patients Based on Artificial Intelligence and PET/MRI
Primary Purpose
Lymphoma, Non Hodgkin Lymphoma, Follicular Lymphoma
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PET/MR scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Lymphoma focused on measuring Lymphoma, Non Hodgkin Lymphoma, Follicular Lymphoma
Eligibility Criteria
Inclusion Criteria:
- patients with newly diagnosed hodgkin's, aggressive non-hodgkin's and follicular lymphoma (for whom the PET/CT is the imaging modality of choice)/
- Patients aged 18 years or older of both sexes.
- Patients treated at Tel-Aviv Sourasky Medical center.
Exclusion Criteria:
- pregnancy,
- contraindication to MRI or to intravenous gadolinium injection.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lymphoma Patients
Arm Description
Outcomes
Primary Outcome Measures
Patients that preform 18F-FDG PET/MRI and the routinely PET/CT
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04154228
First Posted
October 29, 2019
Last Updated
November 4, 2019
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04154228
Brief Title
Non-invasive Evaluation of Lymphoma Patients Based on Artificial Intelligence and PET/MRI
Official Title
Non-invasive Evaluation of Lymphoma Patients Based on Artificial Intelligence and PET/MRI
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2019 (Anticipated)
Primary Completion Date
January 10, 2020 (Anticipated)
Study Completion Date
December 10, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non Hodgkin Lymphoma, Follicular Lymphoma
Keywords
Lymphoma, Non Hodgkin Lymphoma, Follicular Lymphoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lymphoma Patients
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/MR scan
Intervention Description
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).
Primary Outcome Measure Information:
Title
Patients that preform 18F-FDG PET/MRI and the routinely PET/CT
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with newly diagnosed hodgkin's, aggressive non-hodgkin's and follicular lymphoma (for whom the PET/CT is the imaging modality of choice)/
Patients aged 18 years or older of both sexes.
Patients treated at Tel-Aviv Sourasky Medical center.
Exclusion Criteria:
pregnancy,
contraindication to MRI or to intravenous gadolinium injection.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Non-invasive Evaluation of Lymphoma Patients Based on Artificial Intelligence and PET/MRI
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