Non-invasive Evaluation of Lymphoma Patients Based on Artificial Intelligence and PET/MRI

NCT04154228 | Unknown

• 1 other identifier: TASMC-19-ES-0556-CTIL
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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:

1. 1.To evaluate the added value of 18F-FDG PET/MRI compared with PET/CT in imaging lymphoma.
2. 2.To optimize PET/MR imaging protocol for lymphoma assessment.
3. 3.To develop an automated tool for staging patients with lymphoma.
4. 4.To develop an automated method for early prediction of response to therapy and prognosis in patients with lymphoma.
5. 5.To develop an automated non-invasive tool for discriminating benign from active residual masses at end of treatment in patients with lymphoma.

Conditions

Lymphoma; Non Hodgkin Lymphoma; Follicular Lymphoma

Keywords

Lymphoma; Non Hodgkin Lymphoma; Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (1)

Lymphoma Patients

EXPERIMENTAL

Diagnostic Test: PET/MR scan

Interventions

PET/MR scan DIAGNOSTIC_TEST

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).

Lymphoma Patients

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• pregnancy,
• contraindication to MRI or to intravenous gadolinium injection.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Conditions

Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 6, 2019
• Study Start: December 10, 2019
• Primary Completion: January 10, 2020
• Study Completion: December 10, 2021
• Last Updated: November 6, 2019

Record last verified: 2019-11