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

Not Applicable

• Conditions: Follicular Lymphoma; Lymphoma; Non Hodgkin Lymphoma
• Interventions: Diagnostic Test: PET/MR scan

• Registration Number: NCT04154228
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-29
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-04
• Last Update Submitted: 2019-11-04
• Study First Posted: 2019-11-06
• Last Update Posted: 2019-11-06
• Study Start: 2019-12-10
• Primary Completion: 2020-01-10
• Study Completion: 2021-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lymphoma Patients	PET/MR scan	-

Primary Outcome Measures

Name	Time	Method
Patients that preform 18F-FDG PET/MRI and the routinely PET/CT	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.