Lymphoma, Diffuse Large B-CellNCT06777290
Comparison of Whole-body MRI, Circulating DNA and PET-CT in Staging, Prognosis, and Treatment Response in Patients with Diffuse Large Cell B Lymphoma
An observational study of Lymphoma, Diffuse Large B-Cell, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Diffuse Large B-Cell
- How many people
- 14 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to a Department of Hematology at a tertiary university hospital.
Who may be able to join
- 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.
Who cannot join
- history of indolent lymphoma
- anti-lymphoma treatment initiated before PET/CT or wbMRI
- central nervous system lymphoma
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Radiology, General University Hospital in Prague, Prague, Czech Republic
Prague, Prague, 12808
About this study
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.
Read the 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.
- Conditions
- Lymphoma, Diffuse Large B-Cell
- Keywords
- diagnostic performance, whole body MRI, PET/CT, ctDNA
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DLBCL patients | Adult patients newly diagnosed with diffuse large cell B lymphoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline
Secondary outcomes (2)
Diagnostic value of MRI sequences
Rating of the diagnostic utility of MRI sequences used in whole body MRI in staging of DLBCL in newly diagnosed adult patients before treatment
Measured: At baseline
Assessment of therapeutic response
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.
Measured: after completion of first-line treatment, on average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Diffuse Large B-CellStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- General University Hospital, Prague
- Responsible party
- Principal investigator, Lukas Lambert, Charles University, Czech Republic
- Investigators
- Lukas Lambert, prof. M.D. Ph.D., Principal investigator, Department of Radiology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777290
- Sponsor's protocol ID
- 12/20 VFN IGP
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be available upon reasonable request to the corresponding author.
Publications
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.
PubMed 35111648
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06777290
- Acronym / sponsor ID
- 12/20 VFN IGP
- Conditions
- Lymphoma, Diffuse Large B-Cell
- Keywords
- diagnostic performance, whole body MRI, PET/CT, ctDNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- General University Hospital, Prague
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DLBCL patients | – | –Adult patients newly diagnosed with diffuse large cell B lymphoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to a Department of Hematology at a tertiary university hospital.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- history of indolent lymphoma
- anti-lymphoma treatment initiated before PET/CT or wbMRI
- central nervous system lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Diagnostic value of MRI sequences
Time frame: At baseline
Assessment of therapeutic response
Time frame: after completion of first-line treatment, on average 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Background: PubMed 35111648Lambert 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.
- Individual participant dataSharing planned: No. The data will be available upon reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas Lambert, prof. M.D. Ph.D. principal investigator
Department of Radiology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Diffuse Large B-Cell, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of whole-body MRI in staging of DLBCL (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06777290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.