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

NCT ID: NCT06777290

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Lymphoma, Diffuse Large B-Cell

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DLBCL patients

Adult patients newly diagnosed with diffuse large cell B lymphoma

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General University Hospital, Prague

OTHER

Sponsor Role collaborator

Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Lukas Lambert

prof. MD. Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lukas Lambert, prof. M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Prague, Prague, Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type BACKGROUND
PMID: 35111648 (View on PubMed)

Other Identifiers

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12/20 VFN IGP

Identifier Type: -

Identifier Source: org_study_id

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