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

NCT ID: NCT04154228

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2021-12-10

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. To evaluate the added value of 18F-FDG PET/MRI compared with PET/CT in imaging lymphoma.

2. To optimize PET/MR imaging protocol for lymphoma assessment.

3. To develop an automated tool for staging patients with lymphoma.

4. To develop an automated method for early prediction of response to therapy and prognosis in patients with lymphoma.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Lymphoma Patients

Group Type: EXPERIMENTAL

PET/MR scan

Intervention Type: 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).

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TASMC-19-ES-0556-CTIL

Identifier Type: -

Identifier Source: org_study_id