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

Charles University, Czech Republic14 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Lymphoma, Diffuse Large B-Cell

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Radiology, General University Hospital in Prague, Prague, Czech Republic

Prague, Prague, Czechia

Outcomes

Primary Outcomes

Diagnostic accuracy of whole-body MRI in staging of DLBCL

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

Time frame: at baseline

Secondary Outcomes

Diagnostic value of MRI sequences

Rating of the diagnostic utility of MRI sequences used in whole body MRI in staging of DLBCL in newly diagnosed adult patients before treatment

Time frame: At baseline

Assessment of therapeutic response

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.

Time frame: after completion of first-line treatment, on average 6 months

Data from ClinicalTrials.gov

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