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

NCT06777290 | Completed

• 1 other identifier: 12/20 VFN IGP
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma, Diffuse Large B-Cell

Keywords

diagnostic performance; whole body MRI; PET/CT; ctDNA

Outcome Measures

Primary Outcomes (1)

• 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

  at baseline

Secondary Outcomes (2)

• Diagnostic value of MRI sequences

  At baseline

• Assessment of therapeutic response

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

Study Arms (1)

DLBCL patients

Adult patients newly diagnosed with diffuse large cell B lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred to a Department of Hematology at a tertiary university hospital.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• General University Hospital, Prague: collaborator

Study Sites (1)

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

Prague, Prague, 12808, Czechia

Location

Related Publications (1)

• 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.

  PMID: 35111648 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for circulating tumor DNA (ctDNA) analysis

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

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

Study Officials

• Lukas Lambert, prof. M.D. Ph.D.

  Department of Radiology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. MD. Ph.D.

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: January 15, 2025
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)