LymphomaNCT01231269
Whole-body Diffusion-weighted Magnetic Resonance Imaging for Staging and Treatment Prediction of Lymphoma
A study testing MRI in people with Lymphoma and Hodgkin Lymphoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Whole body diffusion-weighted imaging is a functional magnetic resonance imaging technique that characterizes tissue by probing changes in water diffusion secondary to differences in the tissue microstructure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma, Hodgkin Lymphoma, Non-Hodgkin Lymphoma (Follicular, Diffuse B-cel Lymphoma, PTLD and Mantle Cel Lymphoma)
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2010to Dec 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- every patient with a new diagnosis of Hodgkin or Non-Hodgkin Lymphoma (only diffuse large B-cel lymphoma, mantle cell lymphoma, follicular lymphoma and PTLD)
Who cannot join
- patient with general contraindications for MRI (pacemaker, claustrophobia, etc.)
- patients with a type of lymphoma other than those described in the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Whole body diffusion-weighted imaging is a functional magnetic resonance imaging technique that characterizes tissue by probing changes in water diffusion secondary to differences in the tissue microstructure. These changes in water diffusion result in differences in signal intensity on diffusion-weighted-images that are quantified with the apparent diffusion coefficient (ADC). In malignant lesions, the extravascular extracellular space (EES) will be diminished, due to the increased number of cells. This will restrict water diffusion, identified by increased signal intensity (SI) on native DWI images and low ADC. Several studies indicate the value of DWI for differentiation of benign and malignant lymph nodes, detection of tumor recurrence and for ADC-based prediction of treatment outcome in various solid tumours (Koh DM et al, Am J Roentgenol 2007).
Patients with a new diagnosis of Hodgkin or Non-Hodgkin Lymphoma (only diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and PTLD) will be included in the study. These patients will receive a WB-DWI scan before treatment, once or twice during treatment (depending on the type of lymphoma) and after the completion of the treatment. The MRI scan will be performed on a 3 Tesla-MRI system without contrast administration and without exposing the patient to radiation.
Read more
Whole body diffusion-weighted images will be prospectively interpreted by two experienced radiologists, blinded to all clinical and imaging data. Findings will be correlated to FDG-18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose , biopsies performed in clinical routine (bone marrow always - soft tissue lesions if indicated) and imaging follow-up.
The purpose of this study is:
- to evaluate Whole body diffusion-weighted imaging for staging of lymphoma
- to evaluate Whole body diffusion-weighted imaging as an early predictive biomarker for treatment outcome
- to evaluate Whole body diffusion-weighted imaging for differentiating residual tumor from post therapy changes
- Conditions
- Lymphoma, Hodgkin Lymphoma, Non-Hodgkin Lymphoma (Follicular, Diffuse B-cel Lymphoma, PTLD and Mantle Cel Lymphoma)
- Being tested
- MRI
- Medical subject headings
- Lymphoma, Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
MRI scan without administration of contrast/without radiation
| Study group | Role | What they receive |
|---|---|---|
| MRI | Experimental | diffusion-weighted MRI Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease stage
Lesions are characterized as benign or malignant based on signal intensity and ADC values, enabling correct determination of tumor extent (staging).
Measured: 4 years
Secondary outcomes (1)
progression free survival
We will investigate whether there is a correlation between ADC and signal intensity changes during therapy and progression free survival
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2016
- Study completionDec 2025 (estimated)
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 LymphomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- vincent vandecaveye, MD PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231269
- Sponsor's protocol ID
- S51160
- Status last verified
- Jul 2024
- First submitted
- 28 Oct 2010
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
De Paepe KN, Van Keerberghen CA, Agazzi GM, De Keyzer F, Gheysens O, Bechter O, Wolter P, Dierickx D, Janssens A, Verhoef G, Oyen R, Koole M, Vandecaveye V. Quantitative Whole-Body Diffusion-weighted MRI after One Treatment Cycle for Aggressive Non-Hodgkin Lymphoma Is an Independent Prognostic Factor of Outcome. Radiol Imaging Cancer. 2021 Mar 26;3(2):e200061. doi: 10.1148/rycan.2021200061. eCollection 2021 Mar.
PubMed 33817648
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-body Diffusion-weighted Magnetic Resonance Imaging for Staging and Treatment Prediction of Lymphoma
- ClinicalTrials.gov ID
- NCT01231269
- Acronym / sponsor ID
- S51160
- Conditions
- Lymphoma, Hodgkin Lymphoma, Non-Hodgkin Lymphoma (Follicular, Diffuse B-cel Lymphoma, PTLD and Mantle Cel Lymphoma)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Nov 2010 (estimated)
- 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.
Whole body diffusion-weighted imaging is a functional magnetic resonance imaging technique that characterizes tissue by probing changes in water diffusion secondary to differences in the tissue microstructure. These changes in water diffusion result in differences in signal intensity on diffusion-weighted-images that are quantified with the apparent diffusion coefficient (ADC). In malignant lesions, the extravascular extracellular space (EES) will be diminished, due to the increased number of cells. This will restrict water diffusion, identified by increased signal intensity (SI) on native DWI images and low ADC. Several studies indicate the value of DWI for differentiation of benign and malignant lymph nodes, detection of tumor recurrence and for ADC-based prediction of treatment outcome in various solid tumours (Koh DM et al, Am J Roentgenol 2007).
Patients with a new diagnosis of Hodgkin or Non-Hodgkin Lymphoma (only diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and PTLD) will be included in the study. These patients will receive a WB-DWI scan before treatment, once or twice during treatment (depending on the type of lymphoma) and after the completion of the treatment. The MRI scan will be performed on a 3 Tesla-MRI system without contrast administration and without exposing the patient to radiation.
Whole body diffusion-weighted images will be prospectively interpreted by two experienced radiologists, blinded to all clinical and imaging data. Findings will be correlated to FDG-18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose , biopsies performed in clinical routine (bone marrow always - soft tissue lesions if indicated) and imaging follow-up.
The purpose of this study is:
- to evaluate Whole body diffusion-weighted imaging for staging of lymphoma
- to evaluate Whole body diffusion-weighted imaging as an early predictive biomarker for treatment outcome
- to evaluate Whole body diffusion-weighted imaging for differentiating residual tumor from post therapy changes
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI | Experimental | Other: MRIdiffusion-weighted MRI |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- every patient with a new diagnosis of Hodgkin or Non-Hodgkin Lymphoma (only diffuse large B-cel lymphoma, mantle cell lymphoma, follicular lymphoma and PTLD)
Key exclusion criteria (2 listed)
- patient with general contraindications for MRI (pacemaker, claustrophobia, etc.)
- patients with a type of lymphoma other than those described in the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI scan without administration of contrast/without radiation | Other | MRI |
Primary outcome
disease stage
Time frame: 4 years
Lesions are characterized as benign or malignant based on signal intensity and ADC values, enabling correct determination of tumor extent (staging).
1 secondary outcome
progression free survival
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Derived from this study: PubMed 33817648De Paepe KN, Van Keerberghen CA, Agazzi GM, De Keyzer F, Gheysens O, Bechter O, Wolter P, Dierickx D, Janssens A, Verhoef G, Oyen R, Koole M, Vandecaveye V. Quantitative Whole-Body Diffusion-weighted MRI after One Treatment Cycle for Aggressive Non-Hodgkin Lymphoma Is an Independent Prognostic Factor of Outcome. Radiol Imaging Cancer. 2021 Mar 26;3(2):e200061. doi: 10.1148/rycan.2021200061. eCollection 2021 Mar.
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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.
vincent vandecaveye, MD PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Lymphoma and Hodgkin Lymphoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Jul 2024. 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 Belgium. 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?
Results are not available in the source record.
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?
disease stage (time frame: 4 years). 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 NCT01231269, 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 10 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.