Clinical trial 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
Official title: Comparison of Whole-body MRI, Circulating DNA and PET-CT in Staging, Prognosis, and Treatment Response in Patients with Diffuse Large Cell B Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Diffuse Large B-Cell
Keywords: diagnostic performance
whole body MRI
PET/CT
ctDNA
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: General University Hospital, Prague
First posted: 2025-01-15
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred to a Department of Hematology at a tertiary university hospital.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy of whole-body MRI in staging of DLBCL
timeFrame: at baseline
Secondary outcomes:
measure: Diagnostic value of MRI sequences
timeFrame: At baseline
measure: Assessment of therapeutic response
timeFrame: after completion of first-line treatment, on average 6 months
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Department of Radiology, General University Hospital in Prague, Prague, Czech Republic
Study officials:
affiliation: Department of Radiology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic
name: Lukas Lambert, prof. M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lambert L, Burgetova A, Trneny M, Bircakova B, Molinsky J, Benesova K, Zogala D, Michalek P. The diagnostic performance of whole-body MRI in the staging of lymphomas in adult patients compared to PET/CT and enhanced reference standard-systematic review and meta-analysis. Quant Imaging Med Surg. 2022 Feb;12(2):1558-1570. doi: 10.21037/qims-21-649.