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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04154228
• Other study ID #: TASMC-19-ES-0556-CTIL
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: December 10, 2021

Study information

• Verified date: November 2019
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 10, 2021
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma

Intervention

Diagnostic Test:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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