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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
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymphoma focused on measuring Lymphoma, Non Hodgkin Lymphoma, Follicular Lymphoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. patients with newly diagnosed hodgkin's, aggressive non-hodgkin's and follicular lymphoma (for whom the PET/CT is the imaging modality of choice)/
  2. Patients aged 18 years or older of both sexes.
  3. Patients treated at Tel-Aviv Sourasky Medical center.

Exclusion Criteria:

  1. pregnancy,
  2. 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

    First Posted
    October 29, 2019
    Last Updated
    November 4, 2019
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    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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