Comparison of Whole-body MRI, Circulating DNA and PET-CT in Staging, Prognosis, and Treatment Response in Patients with Diffuse Large Cell B Lymphoma

Completed

• Conditions: Lymphoma, Diffuse Large B-Cell

• Registration Number: NCT06777290
• Lead Sponsor: Charles University, Czech Republic

Brief Summary

The aim of the study is to compare the diagnostic performance of whole-body MRI scan, positron emission tomography + CT, and circulating tumor DNA in patients with hematologic malignancy called diffuse large cell B lymphoma (DLBCL) in staging and restaging, and prognosis.

Detailed Description

Patients newly diagnosed with DLBCL or patients with relapsed DLBCL who consent to participate in this study will apart from standard staging and restaging examination with PET/CT undergo whole-body MRI (wbMRI). From blood samples, the level of circulating tumor DNA (ctDNA) fragments will be estimated. These procedures will be repeated during restaging after primary treatment. The diagnostic accuracy of wbMRI in initial staging and restaging will be compared with PET/CT as the gold standard. Circulating tumor DNA levels will be compared at baseline with staging from PET/CT. The change in levels of ctDNA will be compared with the treatement response assessed by PET/CT. All three methods will be used as prognostic indicators.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2025-01-10
• Last Update Submitted: 2025-01-10
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• age ≥18 years
• performance status according to the Eastern Cooperative Oncology Group between 0 and 3
• satisfactory clinical condition to participate in this study
• adequate hematologic and renal functions
• no contraindications to MRI
• recent or planned PET/CT at the institution
• informed consent to participate.

Exclusion Criteria

• history of indolent lymphoma
• anti-lymphoma treatment initiated before PET/CT or wbMRI
• central nervous system lymphoma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of whole-body MRI in staging of DLBCL	at baseline	Comparison of diagnostic accuracy of whole-body MRI in staging of DLBCL in newly diagnosed adult patients before treatment compared to PET/CT as the gold standard

Secondary Outcome Measures

Name	Time	Method
Diagnostic value of MRI sequences	At baseline	Rating of the diagnostic utility of MRI sequences used in whole body MRI in staging of DLBCL in newly diagnosed adult patients before treatment
Assessment of therapeutic response	after completion of first-line treatment, on average 6 months	The assessment of therapeutic response by wbMRI after first-line treatment will be compared to that of PET/CT. Change in circulating tumor DNA will be correlated with therapeutic response assessed by PET/CT.

Trial Locations

Locations (1)

Department of Radiology, General University Hospital in Prague, Prague, Czech Republic; 🇨🇿 Prague, Czech Republic