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OpenTrials
Completed

NCT Number: NCT06777290

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

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.

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Key information

Conditions

Lymphoma, Diffuse Large B-Cell Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Prague, 12808, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnostic accuracy of whole-body MRI in staging of DLBCL

    Time frame: 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 outcomes

  1. Diagnostic value of MRI sequences

    Time frame: 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

  2. Assessment of therapeutic response

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • General University Hospital, Prague

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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