Lymphoma, Diffuse Large B-Cell
Conditions
Keywords
diagnostic performance, whole body MRI, PET/CT, ctDNA
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.
Interventions
None listed
Sponsors
General University Hospital, Prague
Charles University, Czech Republic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Czechia
Outcome results
None listed